PIJ
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Collagen Surgical Mesh Containing Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- Reinforcement of soft tissue where weakness exists.
- Adverse events (MAUDE)
- 2017: 11 · 2018: 17 · 2022: 14
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 |
|---|---|---|
| XenMatrix AB Surgical Graft (K162193) | C. R. Bard | 2016-12-23 |
| XenMatrix AB Surgical Graft (K151177) | C. R. Bard | 2015-07-30 |
| XENMATRIX AB SURGICAL GRAFT (K133223) | C.R. Bard, Inc. | 2014-09-19 |
Track PIJ automatically
Every clearance here is in the API, with alerts when new ones post.