BWA
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Unit, Electrosurgical And Coagulation, With Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1992: 8 · 1993: 2 · 1995: 1 · 2007: 2 · 2015: 22 · 2016: 26
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 |
|---|---|---|
| ALEXANDER BOX, BATTERY, RECHARGEABLE (K963305) | Alexander Mfg. Co. | 1997-04-17 |
| E600B FOOTSWITCH (K874794) | Valleylab, Inc. | 1987-12-14 |
| EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 (K873809) | Zimmer Aspen Labs | 1987-11-20 |
Track BWA automatically
Every clearance here is in the API, with alerts when new ones post.