HDAClass II
Forceps, Obstetrical
21 CFR 884.4400 / Obstetrics/Gynecology
HDA is the FDA product code for Forceps, Obstetrical, a class II device type, regulated under 21 CFR 884.4400. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- HDA
- Device name
- Forceps, Obstetrical
- Regulation
- 21 CFR 884.4400
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 10
- Ingested recalls
- 7
Clearances, product code HDA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1985 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1993 | 1 |
| 1995 | 1 |
| 2002 | 1 |
| 2010 | 2 |
Applicants with the most clearances
Product code HDA| Applicant | Clearances |
|---|---|
| Baxter Healthcare Corporation | 1 |
| Columbia Medical & Surgical, Inc. | 1 |
| Dimeda Instrumente GmbH | 1 |
| Inman Liebelt Corp. | 1 |
| Instrumed International Inc dba Avalign German Specialty Instruments | 1 |
| Kinetic Medical Products | 1 |
| Tekno Medical Optik-Chirurgie GmbH | 1 |
| The Huxley Instrument Corp. | 1 |
| United States Surgical, A Division of Tyco Healthc | 1 |
| Zeppelin Medizinlechnik GmbH | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
