GAO
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Suture, Nonabsorbable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4495
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2012: 28 · 2013: 44 · 2014: 6 · 2019: 14 · 2022: 13 · 2025: 27
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 |
|---|---|---|
| LABELING FOR MYO/WIRE II STERNOTOMY SUTURES (K932513) | Alto Development Corp. | 1994-01-07 |
| AUTO SUTURE STAINLESS STEEL SUTURES* (K872532) | United States Surgical, A Division of Tyco Healthc | 1987-08-05 |
| SHARPOINT STAINLESS STEEL SUTURE (K863034) | Chathamborough Research Group, Inc. | 1986-09-30 |
| DISARP ORIGINAL (K802248) | Unoplast A/S | 1980-09-26 |
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