FDG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Retractor, Fiberoptic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4530
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2002: 3 · 2007: 4 · 2011: 5 · 2012: 8 · 2013: 13 · 2014: 7
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 |
|---|---|---|
| ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA (K964561) | Bioenterics Corp. | 1997-02-11 |
| CHAKOFF ENDOSCOPY (K945421) | Stephen Chakoff, Inc. | 1994-12-23 |
Track FDG automatically
Every clearance here is in the API, with alerts when new ones post.