HFGClass II
Coagulator, Laparoscopic, Unipolar (And Accessories)
21 CFR 884.4160 / Obstetrics/Gynecology
HFG is the FDA product code for Coagulator, Laparoscopic, Unipolar (And Accessories), a class II device type, regulated under 21 CFR 884.4160. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HFG
- Device name
- Coagulator, Laparoscopic, Unipolar (And Accessories)
- Regulation
- 21 CFR 884.4160
- Device class
- Class II
- Review panel
- Obstetrics/Gynecology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 11
- Ingested recalls
- 0
Clearances, product code HFG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1999 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| 2018 | 1 |
Applicants with the most clearances
Product code HFG| Applicant | Clearances |
|---|---|
| Halt Medical, Inc. | 3 |
| Davol, Inc. | 2 |
| Acessa Health, Inc. | 1 |
| Aspen Labs | 1 |
| Intl. Medical, Inc. | 1 |
| Mcgan Technology, LLC | 1 |
| Medicor Corp. | 1 |
| Ratio Design Lab | 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.