510(k) K161558 · GEI Electrosurgical, Cutting & Coagulation & Accessories
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
| Applicant | Bovie Medical Corporation, Clearwater FL, US |
| Decision | Substantially Equivalent, Jul 29, 2016 |
| Received | Jun 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161558
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2021 | Bovie Medical Corporation Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. Open, Classified |
GEI | None listed |
| Feb 1, 2021 | Bovie Medical Corporation HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. Open, Classified |
GEI | None listed |
| Feb 1, 2021 | Bovie Medical Corporation ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures. Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.