FAN
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sigmoidoscope, Rigid, Electrical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) (K232262) | Surgease Innovations Limited | 2023-11-30 |
| URODYNAMIC ANALYZER (K831788) | C.R. Bard, Inc. | 1983-09-12 |
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Every clearance here is in the API, with alerts when new ones post.