FCQ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Light Source, Incandescent, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1997: 2 · 1999: 2 · 2001: 1 · 2004: 1 · 2026: 25
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 |
|---|---|---|
| BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE (K960081) | Mitsubishi Cable America, Inc. | 1996-03-12 |
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Every clearance here is in the API, with alerts when new ones post.