Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator— 510(k) K161134
Substantially EquivalentBovie Medical Corporation
FDA 510(k) clearance K161134 for Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator, Substantially Equivalent on 2016-06-20. Applicant: Bovie Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Bovie Medical Corporation
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Recent devices under product code GEI
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- K170777 — Bovie J-Plasma Precise FLEX Handpiece
- K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
- K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
- K152777 — Bovie Disposable Bipolar Ablator
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.