Gastroenterology, Urology

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