FWB
6 FDA 510(k) clearances · Product code
39 daysmedian time to decision
137 days90th percentile
6clearances measured
FDA profile
- Official device name
- Camera, Television, Surgical, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2011: 22 · 2012: 10 · 2014: 7 · 2016: 11 · 2020: 13 · 2026: 19
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 |
|---|---|---|
| CAMERA, SURGICAL AND ACCESSORIES (K934092) | Envision Medical Corp. | 1994-01-07 |
| SURGICAL VIDEO CAMERA, MODEL 9500 (K902359) | Seitz Technical Products, Inc. | 1990-07-12 |
| SONY COLOR VIDEO CAMERAS AND ACCESSORIES (K884343) | Sony Corp. of America | 1988-11-01 |
| MC-SERIES SURGICAL CAMERAS (K871057) | M.P. Video, Inc. | 1987-04-03 |
| MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 (K855020) | Medline Industries, Inc. | 1986-01-24 |
| MEDICAM (K820829) | M.P. Video, Inc. | 1982-05-03 |
Track FWB automatically
Every clearance here is in the API, with alerts when new ones post.