GAQClass II
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
21 CFR 878.4495 / General, Plastic Surgery
GAQ is the FDA product code for Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, a class II device type, regulated under 21 CFR 878.4495. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- GAQ
- Device name
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Regulation
- 21 CFR 878.4495
- 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
- 32
- Ingested recalls
- 6
Clearances, product code GAQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1991 | 3 |
| 1993 | 3 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 2 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2014 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code GAQ| Applicant | Clearances |
|---|---|
| Ethicon, Inc | 3 |
| Suturtek Incorporated | 3 |
| Synthes (USA) Products LLC | 2 |
| Aesculap Inc | 1 |
| American Cyanamid Co. | 1 |
| Cardio Thoracic Systems | 1 |
| Conextions Medical | 1 |
| Core Essence Orthopaedics, LLC | 1 |
| Cp Medical | 1 |
| Davis & Geck, 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.