GARClass II
Suture, Nonabsorbable, Synthetic, Polyamide
21 CFR 878.5020 / General, Plastic Surgery
GAR is the FDA product code for Suture, Nonabsorbable, Synthetic, Polyamide, a class II device type, regulated under 21 CFR 878.5020. As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and 14 recalls.
Classification record
- Product code
- GAR
- Device name
- Suture, Nonabsorbable, Synthetic, Polyamide
- Regulation
- 21 CFR 878.5020
- 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
- 57
- Ingested recalls
- 14
Clearances, product code GAR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1990 | 3 |
| 1991 | 5 |
| 1992 | 3 |
| 1993 | 7 |
| 1994 | 5 |
| 1996 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 6 |
| 2002 | 1 |
| 2003 | 5 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 3 |
| 2008 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code GAR| Applicant | Clearances |
|---|---|
| S. Jackson, Inc. | 4 |
| Aesculap Inc | 3 |
| Sutures, Ltd. | 3 |
| United States Surgical, A Division of Tyco Healthc | 3 |
| Artimplant AB | 2 |
| Davis & Geck, Inc. | 2 |
| Look, Inc. | 2 |
| TAS Medical Inc | 2 |
| Advance Suture, Inc. | 1 |
| Alcon Laboratories | 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.