FHNClass II
Ligator, Hemorrhoidal
21 CFR 876.4400 / Gastroenterology, Urology
FHN is the FDA product code for Ligator, Hemorrhoidal, a class II device type, regulated under 21 CFR 876.4400. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- FHN
- Device name
- Ligator, Hemorrhoidal
- Regulation
- 21 CFR 876.4400
- Device class
- Class II
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 22
- Ingested recalls
- 5
Clearances, product code FHN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1983 | 1 |
| 1988 | 2 |
| 1996 | 2 |
| 1997 | 2 |
| 1998 | 2 |
| 2000 | 3 |
| 2002 | 2 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code FHN| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 5 |
| Agency for Medical Innovations Inc. | 1 |
| American Medical Systems, Inc. | 1 |
| Beijing Zksk Technology Co., Ltd. | 1 |
| Depuy, Inc. | 1 |
| Don Wilson/Wilson-Cook Medical, Inc. | 1 |
| Erchinger Medizintecnik | 1 |
| Haemoband Surgical Ltd | 1 |
| Inx Medical | 1 |
| Leo Medical Co., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- A.M.I. Agency for Medical Innovations GmbH
- AD Supply Group Limited
- Aesculap Inc
- Allwin Medical Devices Pvt. Ltd.
- Allwin Medical Devices, Inc.
- Alton Shanghai Medical Instruments Co Ltd
- Aspen Surgical Products, Inc.
- Beijing Zksk Technology Co., Ltd.
- Biorad Medisys Pvt. Ltd.
- Bioseal
- Boen Healthcare Co., Ltd.
- Boston Scientific Corporation
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.