| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| NWO | Kit, Catheter, Urinary (Exludes Hiv Testing) | 第 2 类 | 21 CFR 876.5130 | 1 |
| NWP | Suprapubic Cystostomy Catheter Kit | 第 2 类 | 21 CFR 876.5090 | |
| NWS | Kit, Choledochoscope, Flexible And Rigid | 第 2 类 | 21 CFR 876.1500 | 1 |
| NWT | Endoscopic Cholangiogram Kit | 第 2 类 | 21 CFR 876.1500 | |
| NWU | Endoscope Introducer Kit | 第 2 类 | 21 CFR 876.1500 | 3 |
| NYU | Catheter, Hemodialysis, Implanted, Coated | 第 2 类 | 21 CFR 876.5540 | 2 |
| NYV | Gastrointestinal Motility System, Capsule | 第 2 类 | 21 CFR 876.1725 | 5 |
| NZA | Accessories, Germicide, Cleaning, For Endoscopes | 第 2 类 | 21 CFR 876.1500 | 11 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | 第 1 类 | 21 CFR 876.5250 | 1 |
| OCS | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 1 |
| OCT | Anti Fog Solution And Accessories, Endoscopy | 第 2 类 | 21 CFR 876.1500 | 27 |
| OCU | Endoscopic Storage Cover | 第 2 类 | 21 CFR 876.1500 | 6 |
| OCV | Endoscope Holder | 第 2 类 | 21 CFR 876.1500 | 10 |
| OCW | Endoscopic Tissue Approximation Device | 第 2 类 | 21 CFR 876.1500 | 70 |
| OCX | Endoscopic Irrigation/Suction System | 第 2 类 | 21 CFR 876.1500 | 93 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 43 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 第 2 类 | 21 CFR 876.1500 | 74 |
| ODA | Endoscopic Central Control Unit | 第 2 类 | 21 CFR 876.1500 | 18 |
| ODB | Endoscopic Contamination Prevention Sheath | 第 2 类 | 21 CFR 876.1500 | 5 |
| ODC | Endoscope Channel Accessory | 第 2 类 | 21 CFR 876.1500 | 72 |
| ODD | Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula | 第 2 类 | 21 CFR 876.1500 | 18 |
| ODE | Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (G | 第 2 类 | 21 CFR 876.1500 | 20 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 12 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 第 2 类 | 21 CFR 876.1500 | 44 |
| ODN | Ultrafiltration-Controlled Nocturnal Dialysate Delivery System | 第 2 类 | 21 CFR 876.5860 | 2 |
| ODX | Autonomous Extracorporeal Blood Leak Detector/Alarm | 第 2 类 | 21 CFR 876.5820 | 4 |
| OEJ | Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia | 第 2 类 | 21 CFR 876.4300 | |
| OEK | Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia | 第 2 类 | 21 CFR 876.4300 | |
| OHR | Catheter Care Tray | 第 2 类 | 21 CFR 876.5130 | |
| OLH | Orchidometer | 第 1 类 | 21 CFR 876.4730 | |
| ONJ | Dissolvable Gel For Preventing Ureteral Stone Migration | 第 2 类 | 21 CFR 876.4680 | 1 |
| ONW | Hemodialysis System For Home Use | 第 2 类 | 21 CFR 876.5860 | 4 |
| ONY | Oral Removable Retainer For Weight Management | 第 2 类 | 21 CFR 876.5981 | 2 |
| OOW | Applicator For Rectal Suppository | 第 1 类 | 21 CFR 876.4730 | 1 |
| OQT | Prostate Lesion, Documentation, System | 第 2 类 | 21 CFR 876.2050 | 1 |
| OTJ | Laparoscopic Single Port Access Device | 第 2 类 | 21 CFR 876.1500 | 11 |
| OWN | Confocal Optical Imaging | 第 2 类 | 21 CFR 876.1500 | 62 |
| PBP | Rectal Insert | 第 2 类 | 21 CFR 876.5980 | 2 |
| PCU | Pancreatic Stent, Covered, Metallic, Removable | 第 2 类 | 21 CFR 876.5015 | 11 |
| PCV | Endoscopic Leak Tester | 第 2 类 | 21 CFR 876.1500 | 2 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 第 2 类 | 21 CFR 876.1500 | 9 |
| PEH | Hemodialysis Catheter Luer End Cap | 第 2 类 | 21 CFR 876.5540 | 2 |
| PEV | Dialysis Administration Kit | 第 2 类 | 21 CFR 876.5820 | |
| PEW | Implantable Transprostatic Tissue Retractor System | 第 2 类 | 21 CFR 876.5530 | 11 |
| PFH | Venous Window Needle Guide | 第 2 类 | 21 CFR 876.5540 | 1 |
| PGD | Colon Capsule Imaging System | 第 2 类 | 21 CFR 876.1330 | 2 |
| PGU | Spatial Imaging For Display Of Endoscope Position | 第 2 类 | 21 CFR 876.1500 | 1 |
| PHT | Basin For Endoscope Reprocessing | 第 1 类 | 21 CFR 876.1500 | |
| PIA | Vibrator For Climax Control Of Premature Ejaculation | 第 2 类 | 21 CFR 876.5025 | 1 |
| PID | Esophageal Dilator Balloon With Or Without Electrode Sensors | 第 2 类 | 21 CFR 876.5980 | 3 |
| PIE | Esophageal Dilator With Balloon And Electrode Sensors | 第 2 类 | 21 CFR 876.5980 | 2 |
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | 第 2 类 | 21 CFR 876.5980 | 51 |
| PIH | Urethral Insert With Pump For Bladder Drainage | 第 2 类 | 21 CFR 876.5140 | 1 |
| PIN | Kidney Perfusion Kit | 第 2 类 | 21 CFR 876.5880 | |
| PIO | Enteral Specific Transition Connectors | 第 2 类 | 21 CFR 876.5980 | 9 |
| PJH | Dynamic Rectal Control System | 第 2 类 | 21 CFR 876.5930 | 2 |
| PKI | Fully Subcutaneous Implanted Hemodialysis Catheter | 第 2 类 | 21 CFR 876.5540 | |
| PKL | Hemostatic Metal Clip For The Gi Tract | 第 2 类 | 21 CFR 876.4400 | 64 |
| PLI | Gastrointestional Tube Holder | 第 2 类 | 21 CFR 876.5980 | 1 |
| PLL | Submucosal Injection Agent | 第 2 类 | 21 CFR 876.1500 | 9 |
| PLP | High Intensity Ultrasound System For Prostate Tissue Ablation | 第 2 类 | 21 CFR 876.4340 | 13 |
| PLQ | Enzyme Packed Cartridge | 第 2 类 | 21 CFR 876.5985 | 8 |
| PNB | Biliary Stent System For Benign Strictures | 第 2 类 | 21 CFR 876.5011 | 1 |
| PNG | Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwel | 第 2 类 | 21 CFR 876.5630 | 15 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 第 2 类 | 21 CFR 876.5980 | 34 |
| POZ | Biopsy Needle Kit | 第 2 类 | 21 CFR 876.1075 | |
| PPA | Bladder Irrigation Kit | 第 2 类 | 21 CFR 876.5130 | |
| PPB | Foley Catheter Kit (Excludes Hiv Testing) | 第 2 类 | 21 CFR 876.5130 | |
| PPC | Male External Catheterization Kit (Excludes Hiv Testing) | 第 2 类 | 21 CFR 876.5130 | |
| PPD | Universal Drainage Tray | 第 2 类 | 21 CFR 876.5130 | |
| PPE | Nephroscope Set | 第 2 类 | 21 CFR 876.1500 | |
| PPF | Urinary Irrigation Kit | 第 2 类 | 21 CFR 876.5130 | |
| PPG | Urinary Drainage Collection Kit | 第 2 类 | 21 CFR 876.5130 | |
| PPH | Single Needle With Uni-Directional Pump Kit | 第 2 类 | 21 CFR 876.5820 | |
| PPI | Hemodialysis Tray (Not A Start/Stop Kit) | 第 2 类 | 21 CFR 876.5820 | |
| PPJ | Peritoneal Dialysis Administration Kit | 第 2 类 | 21 CFR 876.5630 | |
| PPK | Peritoneal Dialysis Tubing Kit | 第 2 类 | 21 CFR 876.5630 | |
| PPL | Single Needle (Co-Axial Flow) Dialysis Kit | 第 2 类 | 21 CFR 876.5820 | |
| PPO | Multi-Lumen Hemodialysis Catheterization Kit | 第 2 类 | 21 CFR 876.5540 | |
| PQE | Ostomy Care Kit | 第 1 类 | 21 CFR 876.5900 | |
| PRM | Enteral Administration Kit (Adult & Pediatric) | 第 2 类 | 21 CFR 876.5980 | |
| PRO | Anti-Regurgitation Blood Tubing Kit | 第 2 类 | 21 CFR 876.5820 | |
| PRP | Balloon Gastrostomy Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRQ | Esophageal Dilator Kit | 第 2 类 | 21 CFR 876.5365 | |
| PRR | Feeding Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRS | Gastric Colonic Catheter Irrigation Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRT | Gastric Irrigation And Aspiration Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRU | Gastric Lavage Kit (Adult Or Pediatric Use) | 第 2 类 | 21 CFR 876.4370 | |
| PRV | Gastro-Urology Biopsy Kit | 第 2 类 | 21 CFR 876.1075 | |
| PRW | Gastrointestinal Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRX | Gastrostomy Guide Wire Placement Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRY | Gastrostomy Jejunostomy Feeding Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PRZ | Gastrostomy Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSA | Laparoscopic Jejunostomy Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSB | Nasogastric Feed Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSC | Nasogastric-Gastrojejunal Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSD | Laparoscopic Gastrostomy Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSE | Needle Catheter Jejunostomy Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSF | Non-Balloon Replacement Gastrostomy System | 第 2 类 | 21 CFR 876.5980 | |
| PSG | Percutaneous Endoscopic Gastrostomy Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSH | Percutaneous Replacement Gastrostomy Tube Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSI | Perineal Irrigation Kit | 第 2 类 | 21 CFR 876.5980 | |
| PSJ | Rectal Dilator Kit | 第 1 类 | 21 CFR 876.5450 | |
| PSK | Replacement Gastrostomy Feeding Catheter Tray | 第 2 类 | 21 CFR 876.5980 | |
| PSX | Chlorine Meter | 第 2 类 | 21 CFR 876.5665 | 1 |
| PTK | Pediatric Esophageal Atresia Anastomosis Device | 第 3 类 | 21 CFR 876.5980 | |
| PTQ | Endoscopic Magnetic Retriever, Exempt | 第 2 类 | 21 CFR 876.1500 | |
| PTR | Scissors For Cytoscope, Exempt | 第 2 类 | 21 CFR 876.1500 | |
| PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | 第 2 类 | 21 CFR 876.1500 | |
| PTT | Biliary Catheter For Irrigation And Contrast Injection, Exempt | 第 2 类 | 21 CFR 876.5010 | |
| PTU | Catheter, Peritoneal, Long-Term Indwelling, Exempt | 第 2 类 | 21 CFR 876.5630 | |
| PTV | Catheter, Peritoneal Dialysis, Single Use, Exempt | 第 2 类 | 21 CFR 876.5630 | |
| PTW | System, Peritoneal, Automatic Delivery, Exempt | 第 2 类 | 21 CFR 876.5630 | |
| PUP | Endoscope Maintenance System | 第 2 类 | 21 CFR 876.1500 | 1 |
| PVY | Vasovasostomy Set | 第 1 类 | 21 CFR 876.4730 | |
| QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence | 第 2 类 | 21 CFR 876.5330 | 5 |
| QAX | Hemodialyzer With Expanded Solute Removal Profile | 第 2 类 | 21 CFR 876.5862 | 2 |
| QEC | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial | 第 2 类 | 21 CFR 876.4300 | 1 |
| QEF | Pressure Ulcer Management Tool | 第 1 类 | 21 CFR 876.2100 | 1 |
| QEJ | Flushing Solution For Short Term Storage Of Veins At Room Temperature | 第 2 类 | 21 CFR 876.4100 | 2 |
| QFQ | Ingested, Transient, Space Occupying Device For Weight Management And/ | 第 2 类 | 21 CFR 876.5982 | 3 |
| QFZ | Gastroenterology-Urology Accessories To A Biopsy Instrument | 第 1 类 | 21 CFR 876.1080 | |
| QGA | Penile Implant Surgical Accessories | 第 1 类 | 21 CFR 876.3500 | |
| QGB | Ureteral Stent Accessories | 第 1 类 | 21 CFR 876.4630 | |
| QGC | Suprapubic Catheter Accessories | 第 1 类 | 21 CFR 876.5100 | |
| QGD | Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Acce | 第 1 类 | 21 CFR 876.5290 | |
| QGE | Biliary Stent, Drain, And Dilator Accessories | 第 1 类 | 21 CFR 876.5012 | |
| QGG | Esophageal Sheath With Distal Balloon Anchor | 第 2 类 | 21 CFR 876.1510 | 1 |
| QGY | Mobile / Tablet Software Application To Control Settings Of Surgical A | 第 2 类 | 21 CFR 876.1500 | 1 |
| QHC | Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs | 第 2 类 | 21 CFR 876.1075 | |
| QHH | Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowe | 第 2 类 | 21 CFR 876.5340 | 6 |
| QIJ | Endoscopic Transhepatic Venous Access Needle | 第 2 类 | 21 CFR 876.1050 | 1 |
| QIR | Pediatric Hemodialysis System | 第 2 类 | 21 CFR 876.5861 | 1 |
| QIS | Esophageal, Mucosal, Electrical Characterization | 第 2 类 | 21 CFR 876.1450 | 3 |
| QJN | Laparoscopic Accessories, Esophageal Sizing | 第 2 类 | 21 CFR 876.5360 | 2 |
| QKA | Temporarily-Placed Urethral Opening System For Symptoms Of Benign Pros | 第 2 类 | 21 CFR 876.5510 | 4 |
| QKZ | Magnetically Maneuvered Capsule Endoscopy System | 第 2 类 | 21 CFR 876.1310 | 6 |
| QMY | Computerized Behavioral Therapy Device For Treating Symptoms | 第 2 类 | 21 CFR 876.5960 | 3 |
| QNA | Ultrasonic Urinary Stone Propulsion Device | 第 2 类 | 21 CFR 876.4690 | 2 |
| QNE | Endoscopic Pancreatic Debridement Device | 第 2 类 | 21 CFR 876.4330 | 1 |
| QNP | Gastrointesinal Lesion Software Detection System | 第 2 类 | 21 CFR 876.1520 | 22 |
| QON | Implanted Electrical Device Intended For Treatment Of Fecal Incontinen | 第 3 类 | 21 CFR 876.5270 | |
| QRC | Non-Implanted Electrical Stimulation Device For Management Of Prematur | 第 2 类 | 21 CFR 876.5026 | 4 |
| QSM | System, Surgical, Computer Controlled Instrument, Remanufactured | 第 2 类 | 21 CFR 876.1500 | 8 |
| QSW | Endoscopic Traction Device | 第 2 类 | 21 CFR 876.4410 | 2 |
| QTD | Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Los | 第 2 类 | 21 CFR 876.5983 | 2 |
| QTH | Endoscopic Light-Projecting Measuring Device | 第 2 类 | 21 CFR 876.1530 | 1 |
| QTN | Orally Ingested Transient Device For Constipation | 第 2 类 | 21 CFR 876.5940 | 3 |
| QUD | Blood Detection Capsule | 第 2 类 | 21 CFR 876.1390 | 1 |
| QUN | Tether Accessory For Use In The Gastrointestinal Tract | 第 2 类 | 21 CFR 876.1305 | |
| QWW | Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunctio | 第 2 类 | 21 CFR 876.5021 | 1 |
| QXH | Gallbladder Drainage Stent And Delivery System | 第 2 类 | 21 CFR 876.5016 | 1 |
| QXM | Implanted Tibial Electrical Urinary Continence Device | 第 2 类 | 21 CFR 876.5305 | 4 |
| QZB | Software Controlled Endoscope And Instrument Holder | 第 2 类 | 21 CFR 876.1500 | 4 |
| QZF | Gastrointestinal Capsule Endoscopy Analysis Software Device | 第 2 类 | 21 CFR 876.1540 | 2 |
| SBX | Software For Endoscopy Procedure Metrics | 第 2 类 | 21 CFR 876.1500 | |
| SCB | Deflation Needle For Removal Of Intragastric Balloon | 第 2 类 | 21 CFR 876.1550 | |
| SCT | Foley Catheters And Accessories With Additional Safety Features | 第 2 类 | 21 CFR 876.5130 | |
| SFE | Endoscopic Video Imaging System / Software Component For Real Time Vid | 第 2 类 | 21 CFR 876.1500 | 2 |
| SFW | Cranial Electrotherapy Stimulator For Weight Management | 第 1 类 | 21 CFR 876.5984 | 1 |
| SGY | Hypothermic Machine Perfusion System And Accessories For Orthotopic Li | 第 2 类 | 21 CFR 876.5881 | 1 |
| SHU | Appendiceal Scope And Accessories, Flexible | 第 2 类 | 21 CFR 876.1500 | 1 |
| SHV | Reusable Intermittent Urinary Catheter System | 第 2 类 | 21 CFR 876.5120 | 1 |
| SJB | Powered Fecal Management System | 第 2 类 | 21 CFR 876.5230 | 1 |