GAN — Suture, Absorbable, Synthetic Class II
FDA product code GAN covers "Suture, Absorbable, Synthetic", a Class II medical device regulated under 21 CFR 878.4830. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GAN
- Device Class
- Class II
- Regulation Number
- 878.4830
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003015 | surgical specialties | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | December 15, 2000 |
| K964072 | ethicon | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | December 18, 1996 |
| K960653 | ethicon | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | March 28, 1996 |
| K951231 | sterile concepts | ORTHOPEDIC PACKS | December 1, 1995 |
| K920978 | ethicon | ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED | February 15, 1994 |
| K895579 | united states surgical, a division of tyco healthc | POLYSORB SYNTHETIC ABSORBABLE SUTURE | July 5, 1990 |
| K900198 | american cyanamid | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | July 5, 1990 |