GANClass II
Suture, Absorbable, Synthetic
21 CFR 878.4830 / General, Plastic Surgery
GAN is the FDA product code for Suture, Absorbable, Synthetic, a class II device type, regulated under 21 CFR 878.4830. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- GAN
- Device name
- Suture, Absorbable, Synthetic
- Regulation
- 21 CFR 878.4830
- 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
- 7
- Ingested recalls
- 2
Clearances, product code GAN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 2000 | 1 |
Applicants with the most clearances
Product code GAN| Applicant | Clearances |
|---|---|
| Ethicon, Inc | 3 |
| American Cyanamid Co. | 1 |
| Sterile Concepts, Inc. | 1 |
| Surgical Specialties Corp | 1 |
| United States Surgical, A Division of Tyco Healthc | 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.
