FTLClass II
Mesh, Surgical, Polymeric
21 CFR 878.3300 / General, Plastic Surgery
FTL is the FDA product code for Mesh, Surgical, Polymeric, a class II device type, regulated under 21 CFR 878.3300. As of , FDA records hold 336 510(k) clearances under this code, the most recent dated , and 73 recalls.
Classification record
- Product code
- FTL
- Device name
- Mesh, Surgical, Polymeric
- Regulation
- 21 CFR 878.3300
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 336
- Ingested recalls
- 73
Clearances, product code FTL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 2 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 5 |
| 1994 | 9 |
| 1995 | 9 |
| 1996 | 12 |
| 1997 | 9 |
| 1998 | 7 |
| 1999 | 8 |
| 2000 | 13 |
| 2001 | 10 |
| 2002 | 6 |
| 2003 | 12 |
| 2004 | 9 |
| 2005 | 14 |
| 2006 | 18 |
| 2007 | 20 |
| 2008 | 23 |
| 2009 | 15 |
| 2010 | 18 |
| 2011 | 15 |
| 2012 | 12 |
| 2013 | 8 |
| 2014 | 11 |
| 2015 | 12 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 12 |
| 2019 | 4 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 6 |
| 2023 | 4 |
| 2024 | 2 |
| 2025 | 6 |
| 2026 | 1 |
Applicants with the most clearances
Product code FTL| Applicant | Clearances |
|---|---|
| W. L. Gore & Associates, Inc. | 37 |
| Sofradim Production | 36 |
| C.R. Bard Inc | 25 |
| Ethicon, Inc | 25 |
| Atrium Medical Corporation | 14 |
| Davol Inc., Sub. C.R. Bard, Inc. | 8 |
| Tissue Technologies, Inc. | 6 |
| Biomerix Corporation | 5 |
| Medtronic, Inc. | 5 |
| Proxy Biomedical Ltd. | 5 |
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.