FEI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instrument, Special Lens, For Endoscope
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1998: 1 · 1999: 1 · 2003: 1
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 |
|---|---|---|
| M-LENS (THIRTY DEGREE ENDOSCOPE) (K873795) | Opto Vision, Inc. | 1988-01-14 |
| FLEXIBLE VISUALIZATION CATHETER (K862872) | American Edwards Laboratories | 1986-10-24 |
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