FWC
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Camera, Television, Surgical, With Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 1996: 1 · 1997: 1 · 2021: 22 · 2022: 17
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 |
|---|---|---|
| BR-S601MU (SURGICAL VIDEO RECORDER) (K890119) | Victor Co. of Japan, Ltd. C/O Jvc Corp. | 1989-01-24 |
| LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM (K864381) | Luxtec Corp. | 1986-12-09 |
| KY-M280U SURGICAL CAMERA (K854988) | Us Jvc Corp. | 1986-01-24 |
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Every clearance here is in the API, with alerts when new ones post.