| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| OJF | Hysterectomy Kit | 第 2 类 | 21 CFR 884.4530 | |
| OKU | Emergency Obstetrical Kit | 第 1 类 | 21 CFR 884.4520 | |
| OKV | Obstetrical Kit | 第 2 类 | 21 CFR 884.4520 | |
| OKW | Seminal Fluid Collection Kit | 第 2 类 | 21 CFR 884.5300 | |
| OKX | Trocar Kit | 第 2 类 | 21 CFR 884.1720 | |
| OKY | Cytology Kit | 第 2 类 | 21 CFR 884.4530 | |
| OKZ | Endometrial Sampling Kit | 第 2 类 | 21 CFR 884.1175 | |
| ONX | Ovarian Adnexal Mass Assessment Score Test System | 第 2 类 | 21 CFR 866.6050 | 6 |
| OOA | Hemorrhoid Prevention Pressure Wedge | 第 2 类 | 21 CFR 884.5200 | 1 |
| OQY | Intrauterine Tamponade Balloon | 第 2 类 | 21 CFR 884.4530 | 11 |
| OSP | Uterine Electromyographic Monitor | 第 2 类 | 21 CFR 884.2720 | 10 |
| OSV | Insufflator, Endoscopic Vessel Harvesting | 第 2 类 | 21 CFR 884.1730 | |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, | 第 3 类 | 21 CFR 884.5980 | 31 |
| OYO | Culture, Intravaginal, Assisted Reproduction | 第 2 类 | 21 CFR 884.6165 | 2 |
| PAI | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolap | 第 3 类 | 21 CFR 884.5980 | 2 |
| PBH | Embryo Image Assessment System, Assisted Reproduction | 第 2 类 | 21 CFR 884.6195 | 5 |
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | 第 2 类 | 21 CFR 884.4530 | 8 |
| PCF | Sampler, Endocervical | 第 2 类 | 21 CFR 884.1050 | 5 |
| PEB | Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | 第 2 类 | 21 CFR 884.5300 | 10 |
| PFJ | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor | 第 2 类 | 21 CFR 884.4260 | 2 |
| PGK | Cannula, Injector, Uterine, Endometrial Biopsy | 第 2 类 | 21 CFR 884.4530 | 2 |
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutt | 第 2 类 | 21 CFR 884.1710 | 3 |
| PKN | Dilator, Cervical, Synthetic, Osmotic | 第 2 类 | 21 CFR 884.4260 | 1 |
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument P | 第 2 类 | 21 CFR 884.4050 | 4 |
| PNU | Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery | 第 2 类 | 21 CFR 884.5210 | 1 |
| PON | Catheter, Balloon, Dilation Of Cervical Canal | 第 2 类 | 21 CFR 884.4260 | 4 |
| PTE | Endoscopic Morcellator Gastroenterology | 第 2 类 | 21 CFR 884.1690 | 2 |
| PTZ | Colposcope (And Colpomicroscope), Exempt | 第 2 类 | 21 CFR 884.1630 | |
| PUA | Tenaculum, Uterine, Exempt | 第 2 类 | 21 CFR 884.4530 | |
| PUB | Accessory, Assisted Reproduction, Exempt | 第 2 类 | 21 CFR 884.6120 | 1 |
| PUC | Microtools, Assisted Reproduction (Pipettes), Exempt | 第 2 类 | 21 CFR 884.6130 | |
| PUD | Labware, Assisted Reproduction, Exempt | 第 2 类 | 21 CFR 884.6160 | |
| PVR | D&C Tray | 第 2 类 | 21 CFR 884.4530 | |
| PVS | Fetal Blood Sampling Kit (Excludes Hiv Testing) | 第 2 类 | 21 CFR 884.1560 | |
| PVT | Maternity Kit | 第 1 类 | 21 CFR 884.5435 | |
| PVU | Obstetrical Anesthesia Kit | 第 2 类 | 21 CFR 884.5100 | |
| PVV | Paracervical Anesthesia Kit | 第 2 类 | 21 CFR 884.5100 | |
| PVW | Pudendal Anesthesia Kit | 第 2 类 | 21 CFR 884.5100 | |
| PVX | Vaginal Examination Tray | 第 2 类 | 21 CFR 884.4530 | |
| PWA | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure | 第 1 类 | 21 CFR 884.5150 | |
| PWB | Fetal Head Elevator | 第 2 类 | 21 CFR 884.4350 | 2 |
| PWI | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of | 第 2 类 | 21 CFR 884.4910 | 2 |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Inconti | 第 2 类 | 21 CFR 884.4910 | 5 |
| PWK | Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair | 第 2 类 | 21 CFR 884.4910 | 1 |
| PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | 第 2 类 | 21 CFR 884.5370 | 7 |
| QAG | Endoscopic Electrosurgical Clip Cutting System | 第 2 类 | 21 CFR 876.4310 | 1 |
| QFT | Digital Therapeutic Software For Attention Deficit Hyperactivity Disor | 第 2 类 | 21 CFR 882.5803 | 4 |
| QHZ | Seal, Cervical, Mechanical, Unpowered | 第 1 类 | 21 CFR 884.1690 | |
| QKH | Assisted Reproduction Laminar Flow Workstation | 第 2 类 | 21 CFR 884.6120 | |
| QKI | Media, Reproductive, Exempt | 第 2 类 | 21 CFR 884.6180 | |
| QPD | Personal Lubricant Ring | 第 2 类 | 21 CFR 884.5300 | 1 |
| QQR | Circumcision Device With Stapler | 第 2 类 | 21 CFR 884.4530 | |
| QRZ | External Condom For Anal Intercourse Or Vaginal Intercourse | 第 2 类 | 21 CFR 884.5305 | 1 |
| QUJ | Automated Cryopreservation Storage System | 第 2 类 | 21 CFR 884.6120 | 1 |
| QYZ | At Home Intravaginal Insemination System | 第 2 类 | 21 CFR 884.6110 | 3 |
| SIM | Gynecologic Power Morcellator And Containment System | 第 2 类 | 21 CFR 884.4075 | 1 |