FTS
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Camera, Cine, Endoscopic, With Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2002: 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 |
|---|---|---|
| MEC-1 VIDEO COMBO SYSTEM (K883944) | Medical Concepts, Inc. | 1988-09-28 |
| CCM-1 VIDEO CAMERA SYSTEM (K883943) | Medical Concepts, Inc. | 1988-09-28 |
Track FTS automatically
Every clearance here is in the API, with alerts when new ones post.