KNFClass II
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
21 CFR 884.4160 / Obstetrics/Gynecology
KNF is the FDA product code for Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), a class II device type, regulated under 21 CFR 884.4160. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- KNF
- Device name
- Coagulator-Cutter, Endoscopic, 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
- 45
- Ingested recalls
- 5
Clearances, product code KNF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1987 | 1 |
| 1990 | 1 |
| 1994 | 8 |
| 1995 | 6 |
| 1997 | 5 |
| 1998 | 4 |
| 2001 | 3 |
| 2002 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code KNF| Applicant | Clearances |
|---|---|
| Gynesonics, Inc. | 7 |
| Karl Storz Endoscopy-America, Inc. | 4 |
| American Hydro-Surgical Instruments, Inc. | 2 |
| Kli | 2 |
| LiNA Medical Inc | 2 |
| Omnitech Systems, Inc. | 2 |
| Apyx Medical Corporation | 1 |
| Aesculap Inc | 1 |
| Atc Technologies Inc. | 1 |
| Buckman Co., Inc. | 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.