Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices
FDA submissions for Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices in the Obstetrics/Gynecology (OB) review panel, including product codes and regulations.
Section range: §§ 884.4050–884.4910
CFR Part: 884
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| PMU | Containment System, Laparoscopic Power Morcellation, With Instrument Port | 884.4050 | 2 | 4 |
| HIM | Electrocautery, Endoscopic And Accessories | 884.4100 | 2 | 0 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 884.4120 | 2 | 53 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 884.4150 | 2 | 16 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | 884.4160 | 2 | 11 |
| HFH | Coagulator, Hysteroscopic (And Accessories) | 884.4160 | 2 | 0 |
| HFI | Coagulator, Culdoscopic (And Accessories) | 884.4160 | 2 | 8 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 884.4160 | 2 | 44 |
| HDN | Dilator, Cervical, Expandable | 884.4250 | 3 | 0 |
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | 884.4260 | 2 | 11 |
| PFJ | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor | 884.4260 | 2 | 2 |
| PKN | Dilator, Cervical, Synthetic, Osmotic | 884.4260 | 2 | 1 |
| PON | Catheter, Balloon, Dilation Of Cervical Canal | 884.4260 | 2 | 4 |
| HHG | Dilator, Cervical, Vibratory | 884.4270 | 3 | 0 |
| HDB | Extractor, Vacuum, Fetal | 884.4340 | 2 | 30 |
| OHC | Obstetrical Vacuum Delivery Kit | 884.4340 | 2 | 0 |
| PWB | Fetal Head Elevator | 884.4350 | 2 | 2 |
| HDA | Forceps, Obstetrical | 884.4400 | 2 | 10 |
| HDI | Hook, Destructive, Obstetrical | 884.4500 | 2 | 0 |
| HFZ | Craniotribe | 884.4500 | 2 | 0 |
| HGA | Cranioclast | 884.4500 | 2 | 0 |
| HHN | Cleidoclast | 884.4500 | 2 | 0 |
| KNB | Instrument, Destructive, Fetal, Obstetric | 884.4500 | 2 | 1 |
| HDE | Hook, Fibroid, Gynecological | 884.4520 | 1 | 0 |
| HDF | Speculum, Vaginal, Metal | 884.4520 | 1 | 11 |
| HDG | Speculum, Vaginal, Metal, Fiberoptic | 884.4520 | 1 | 2 |
| HDJ | Scissors, Umbilical | 884.4520 | 1 | 1 |
| HDK | Scissors, Episiotomy | 884.4520 | 1 | 0 |
| HDL | Retractor, Vaginal | 884.4520 | 1 | 2 |
| HDM | Packer, Uterine | 884.4520 | 1 | 0 |
| HER | Pelvimeter, External | 884.4520 | 1 | 0 |
| HGC | Clamp, Uterine | 884.4520 | 1 | 2 |
| HGD | Applicator, Vaginal | 884.4520 | 1 | 1 |
| KOH | Instrument, Manual, General Obstetric-Gynecologic | 884.4520 | 1 | 15 |
| OKU | Emergency Obstetrical Kit | 884.4520 | 1 | 0 |
| OKV | Obstetrical Kit | 884.4520 | 2 | 0 |
| FHG | Bell, Circumcision | 884.4530 | 2 | 2 |
| FHJ | Shield, Circumcision | 884.4530 | 2 | 2 |
| HCY | Curette, Uterine | 884.4530 | 1 | 11 |
| HCZ | Forceps, Surgical, Gynecological | 884.4530 | 2 | 24 |
| HDC | Tenaculum, Uterine | 884.4530 | 2 | 20 |
| HDH | Needle, Cerclage, Gynecological | 884.4530 | 1 | 0 |
| HDP | Elevator, Uterine | 884.4530 | 2 | 4 |
| HDQ | Dilator, Cervical, Fixed Size | 884.4530 | 1 | 6 |
| HDZ | Knife, Cervical Cone | 884.4530 | 2 | 0 |
| HFB | Forceps, Biopsy, Gynecological | 884.4530 | 1 | 22 |
| HFW | Clamp, Umbilical | 884.4530 | 2 | 36 |
| HFX | Clamp, Circumcision | 884.4530 | 2 | 27 |
| HGE | Amniotome | 884.4530 | 1 | 6 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | 884.4530 | 1 | 6 |
| HHM | Sound, Uterine | 884.4530 | 1 | 10 |
| HHO | Screw, Fibroid, Gynecological | 884.4530 | 2 | 2 |
| HHT | Spatula, Cervical, Cytological | 884.4530 | 2 | 73 |
| HIB | Speculum, Vaginal, Nonmetal | 884.4530 | 2 | 72 |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | 884.4530 | 2 | 5 |
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | 884.4530 | 2 | 58 |
| LBX | Pelvimeter, Internal | 884.4530 | 2 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 884.4530 | 2 | 87 |
| MDG | System, Intrafallopian Cannula | 884.4530 | 2 | 1 |
| MLS | Labor And Delivery Kit | 884.4530 | 2 | 6 |
| MLT | Pelvic Exam Kit | 884.4530 | 2 | 1 |
| MOV | Catheters, Salpingography | 884.4530 | 2 | 5 |
| MPU | Source, Chemiluminescent Light | 884.4530 | 2 | 2 |
| NBZ | Clamp And Cutter, Umbilical | 884.4530 | 2 | 1 |
| NMG | Forceps, Biopsy, Gynecological, Reprocessed | 884.4530 | 2 | 0 |
| OHG | Circumcision Tray | 884.4530 | 2 | 0 |
| OHL | Pap Smear Kit | 884.4530 | 2 | 0 |
| OJF | Hysterectomy Kit | 884.4530 | 2 | 0 |
| OKY | Cytology Kit | 884.4530 | 2 | 0 |
| OQY | Intrauterine Tamponade Balloon | 884.4530 | 2 | 10 |
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | 884.4530 | 2 | 8 |
| PGK | Cannula, Injector, Uterine, Endometrial Biopsy | 884.4530 | 2 | 2 |
| PUA | Tenaculum, Uterine, Exempt | 884.4530 | 2 | 0 |
| PVR | D&C Tray | 884.4530 | 2 | 0 |
| PVX | Vaginal Examination Tray | 884.4530 | 2 | 0 |
| QQR | Circumcision Device With Stapler | 884.4530 | 2 | 0 |
| HHR | Laser, Surgical, Gynecologic | 884.4550 | 2 | 48 |
| LLW | Laser, Neodymium:Yag For Gynecologic Use | 884.4550 | 2 | 1 |
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | 884.4900 | 2 | 7 |
| HHP | Table, Obstetrical, Manual (And Accessories) | 884.4900 | 2 | 2 |
| KNC | Table, Obstetric (And Accessories) | 884.4900 | 2 | 26 |
| PWI | Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse | 884.4910 | 2 | 2 |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | 884.4910 | 2 | 5 |
| PWK | Instrumentation, Surgical Mesh, Urogynecologic, Transabdominal Repair Of Pelvic Organ Prolapse | 884.4910 | 2 | 1 |
