Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices
FDA submissions for Part 884 Subpart B—Obstetrical and Gynecological Diagnostic Devices in the Obstetrics/Gynecology (OB) review panel, including product codes and regulations.
Section range: §§ 884.1040–884.1730
CFR Part: 884
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| LHZ | Viscometer, Mucus, Cervical | 884.1040 | 1 | 1 |
| HFC | Aspirator, Endocervical | 884.1050 | 2 | 11 |
| PCF | Sampler, Endocervical | 884.1050 | 2 | 5 |
| HFF | Aspirator, Endometrial | 884.1060 | 2 | 5 |
| HFE | Brush, Endometrial | 884.1100 | 2 | 9 |
| HHK | Curette, Suction, Endometrial (And Accessories) | 884.1175 | 2 | 42 |
| OKZ | Endometrial Sampling Kit | 884.1175 | 2 | 0 |
| HFD | Washer, Endometrial | 884.1185 | 2 | 3 |
| HES | Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | 884.1300 | 2 | 13 |
| HIR | Perineometer | 884.1425 | 2 | 64 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 884.1550 | 1 | 20 |
| HGW | Sampler, Blood, Fetal | 884.1560 | 2 | 4 |
| PVS | Fetal Blood Sampling Kit (Excludes Hiv Testing) | 884.1560 | 2 | 0 |
| HFA | Amnioscope, Transabdominal (Fetoscope) (And Accessories) | 884.1600 | f | 0 |
| HEX | Colposcope (And Colpomicroscope) | 884.1630 | 2 | 56 |
| MOK | Vaginoscope And Accessories | 884.1630 | 2 | 2 |
| OHE | Forensic Evidence Sexual Assault Kit | 884.1630 | 2 | 0 |
| PTZ | Colposcope (And Colpomicroscope), Exempt | 884.1630 | 2 | 0 |
| HEW | Culdoscope (And Accessories) | 884.1640 | 2 | 18 |
| OHF | Culdocentesis Kit | 884.1640 | 2 | 0 |
| HEZ | Endoscope, Transcervical (Amnioscope)(And Accessories) | 884.1660 | 2 | 0 |
| HGK | Endoscope, Fetal Blood Sampling (And Accessories) | 884.1660 | 2 | 1 |
| HIH | Hysteroscope (And Accessories) | 884.1690 | 2 | 169 |
| MKO | Falloposcope | 884.1690 | 2 | 4 |
| NWW | Hysteroscope Accessories | 884.1690 | 1 | 0 |
| PTE | Endoscopic Morcellator Gastroenterology | 884.1690 | 2 | 2 |
| QHZ | Seal, Cervical, Mechanical, Unpowered | 884.1690 | 1 | 0 |
| HIG | Insufflator, Hysteroscopic | 884.1700 | 2 | 56 |
| NVT | Tubing And Tubing/Filter Fits | 884.1700 | 1 | 0 |
| PGT | Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar | 884.1710 | 2 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 884.1720 | 2 | 338 |
| NMH | Laparoscope And Accessories, Gynecologic, Reprocessed | 884.1720 | 2 | 0 |
| NWV | Laparoscopic Accessories, Gynecologic | 884.1720 | 1 | 0 |
| OCQ | Laparoscopic Bladder-Neck Suspension Instrument, Stress Urinary Incontinence | 884.1720 | 2 | 0 |
| OHD | Gynecological Laparoscopic Kit | 884.1720 | 2 | 0 |
| OHM | Cesarean Section Tray | 884.1720 | 2 | 0 |
| OKX | Trocar Kit | 884.1720 | 2 | 0 |
| HIF | Insufflator, Laparoscopic | 884.1730 | 2 | 177 |
| NKC | Tubing/Tubing With Filter, Insufflation, Laparoscopic | 884.1730 | 1 | 0 |
| NMI | Laparoscopic Insufflator And Accessories, Reprocessed | 884.1730 | 1 | 0 |
| OSV | Insufflator, Endoscopic Vessel Harvesting | 884.1730 | 2 | 0 |
