GAN
7 FDA 510(k) clearances · Product code
170 daysmedian time to decision
715 days90th percentile
7clearances measured
FDA profile
- Official device name
- Suture, Absorbable, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4830
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 301 · 2022: 327 · 2023: 343 · 2024: 450 · 2025: 423 · 2026: 240
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD (K003015) | Surgical Specialties Corp | 2000-12-15 |
| MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (K964072) | ETHICON, Inc. | 1996-12-18 |
| MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) (K960653) | ETHICON, Inc. | 1996-03-28 |
| ORTHOPEDIC PACKS (K951231) | Sterile Concepts, Inc. | 1995-12-01 |
| ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED (K920978) | ETHICON, Inc. | 1994-02-15 |
| DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (K900198) | American Cyanamid Co. | 1990-07-05 |
| POLYSORB SYNTHETIC ABSORBABLE SUTURE (K895579) | United States Surgical, A Division of Tyco Healthc | 1990-07-05 |
Track GAN automatically
Every clearance here is in the API, with alerts when new ones post.