KGNUnclassified
Wound Dressing With Animal-Derived Material(S)
Unknown
KGN is the FDA product code for Wound Dressing With Animal-Derived Material(S). As of , FDA records hold 191 510(k) clearances under this code, the most recent dated , and 23 recalls.
Classification record
- Product code
- KGN
- Device name
- Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Review panel
- Unknown
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 192
- Ingested recalls
- 23
Clearances, product code KGN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1984 | 1 |
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 3 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 6 |
| 2001 | 2 |
| 2002 | 6 |
| 2003 | 2 |
| 2004 | 5 |
| 2005 | 1 |
| 2006 | 7 |
| 2007 | 3 |
| 2008 | 6 |
| 2009 | 8 |
| 2010 | 4 |
| 2011 | 7 |
| 2012 | 8 |
| 2013 | 6 |
| 2014 | 5 |
| 2015 | 7 |
| 2016 | 4 |
| 2017 | 7 |
| 2018 | 6 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 12 |
| 2023 | 9 |
| 2024 | 13 |
| 2025 | 10 |
| 2026 | 13 |
Applicants with the most clearances
Product code KGN| Applicant | Clearances |
|---|---|
| ACell, Inc | 10 |
| Collagen Matrix, Inc | 8 |
| Innocoll Pharmaceuticals | 8 |
| Integra LifeSciences Corporation | 7 |
| Geistlich Pharma AG | 5 |
| Kerecis Limited | 5 |
| Reprise Biomedical, Inc. | 5 |
| Integra LifeSciences Braintree Inc. | 5 |
| AROA Biosurgery Inc. | 4 |
| Bionova Medical, Inc. | 4 |
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.