FBM
9 FDA 510(k) clearances · Product code
50 daysmedian time to decision
263 days90th percentile
9clearances measured
FDA profile
- Official device name
- Cannula And Trocar, Suprapubic, Non-Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5090
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1992: 1 · 1995: 1 · 2002: 1 · 2003: 1 · 2005: 5 · 2006: 3
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 |
|---|---|---|
| DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) (K960400) | Snowden-Pencer | 1996-03-12 |
| ENTREE CANNULA FASCIA ANCHORS (K932021) | Core Dynamics, Inc. | 1994-01-11 |
| ENTREE CANNULA (K911813) | Core Dynamics, Inc. | 1991-07-19 |
| GS-4000 REDUCER SLEEVE, 11MM TO 5MM (K900955) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4550 TROCAR ONLY, 11MM (K900965) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4300 CANNULA AND TROCAR, 5.5MM (K900962) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4100 REDUCER SLEEVE, 5MM TO 3MM (K900961) | Solos Endoscopy, Inc. | 1990-04-18 |
| GS-4350 TROCAR ONLY, 5.5MM (K900963) | Solos Endoscopy, Inc. | 1990-04-18 |
| CANNULA AND TROCAR, 11MM (K900964) | Solos Endoscopy, Inc. | 1990-04-18 |
Track FBM automatically
Every clearance here is in the API, with alerts when new ones post.