FFO
5 FDA 510(k) clearances · Product code
79 daysmedian time to decision
130 days90th percentile
5clearances measured
FDA profile
- Official device name
- Retractor, Self-Retaining
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2002: 3 · 2003: 2 · 2004: 1 · 2008: 2 · 2016: 32 · 2017: 20
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 |
|---|---|---|
| SPACE-OR RETRACTOR (K993544) | Advanced Surgical Concepts (Asc) | 1999-12-22 |
| KODNER ANAL PERIONEAL RETRACTOR (K870897) | Sur-Med Instruments, Inc. | 1987-06-04 |
| URDYN 5000 (UROFLOWMETER) (K860368) | Dantec Electronics, Inc. | 1986-04-23 |
| URODYN 1000 (K853119) | Dantec Electronics, Inc. | 1985-10-04 |
| THE KENDALL URINARY OUTPUT MONITOR (K852083) | The Kendal Co. | 1985-09-20 |
Track FFO automatically
Every clearance here is in the API, with alerts when new ones post.