MFJ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Endoscopic Suturing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2008: 112 · 2009: 115 · 2010: 40 · 2011: 22 · 2012: 11 · 2015: 11
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 |
|---|---|---|
| SUTURE APPLIER DEVICE (K905722) | Laparomed Corp. | 1991-03-14 |
Track MFJ automatically
Every clearance here is in the API, with alerts when new ones post.