DWG
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Electrosurgical Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2003: 1 · 2010: 5 · 2012: 13 · 2013: 122 · 2014: 84 · 2015: 9
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 |
|---|---|---|
| MAHE INSTRUMENTS (K942823) | Mahe Intl., Inc. | 1994-12-05 |
| TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE (K932345) | Conmedcorp | 1994-04-12 |
| HAND-TROL S (K931215) | Aspen Labs | 1994-03-28 |
| DISPOSABLE ELECTROSURGERY BALL ELECTRODE (K925708) | Beacon Laboratories, Inc. | 1993-04-20 |
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Every clearance here is in the API, with alerts when new ones post.