510(k) K170188 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
| Applicant | Bovie Medical Corporation, Clearwater FL, US |
| Decision | Substantially Equivalent, Mar 8, 2017 |
| Received | Jan 23, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2020 | Bovie Medical Corporation Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cuttin Terminated |
GEI | None listed |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS Terminated |
GEI | None listed |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N Terminated |
GEI | None listed |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B Terminated |
GEI | None listed |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR Terminated |
GEI | None listed |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.