510(k) K152570 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie J-Plasma Precise 360 Handpiece
| Applicant | Bovie Medical Corporation, Clearwater FL, US |
| Decision | Substantially Equivalent, Nov 2, 2015 |
| Received | Sep 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152570
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2018 | Bovie Medical Corporation J-Plasma Precise 360, single use, disposable.
The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open Terminated |
GEI | None listed |
| Jul 18, 2016 | Bovie Medical Corporation BVX-330BR Bovie Precise 360 Handpiece 33cm, blade
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical p Terminated |
GEI | None listed |
| Jul 18, 2016 | Bovie Medical Corporation BVX-330NR Bovie Precise 360 Handpiece 33cm, needle
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical Terminated |
GEI | None listed |
| Jul 18, 2016 | Bovie Medical Corporation BVX-450BR Bovie Precise 360 Handpiece 45cm, blade
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical pr Terminated |
GEI | None listed |
| Jul 18, 2016 | Bovie Medical Corporation BVX-450NR Bovie Precise 360 Handpiece 45cm, needle
Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.