Company · US
Bovie Medical Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2019. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
15recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 12, 2019 | K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpiece Bovie Medical Corporation | GEI |
| Mar 21, 2018 | K180211 | Freezpoint Bovie Medical Corp. | GEH |
| May 1, 2017 | K170777 | Bovie J-Plasma Precise FLEX Handpiece Bovie Medical Corporation | GEI |
| Mar 8, 2017 | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator Bovie Medical Corporation | GEI |
| Jul 29, 2016 | K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, N Bovie Medical Corporation | GEI |
| Jun 20, 2016 | K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Gen Bovie Medical Corporation | GEI |
| Jan 15, 2016 | K152777 | Bovie Disposable Bipolar Ablator Bovie Medical Corporation | GEI |
| Nov 2, 2015 | K152570 | Bovie J-Plasma Precise 360 Handpiece Bovie Medical Corporation | GEI |
| Aug 4, 2015 | K151325 | Bovie J-Plasma Handpiece Bovie Medical Corporation | GEI |
| Dec 12, 2014 | K142975 | Bovie Ultimate High Frequency Electrosurgical Generator Bovie Medical Corporation | GEI |
| Mar 17, 2014 | K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR Bovie Medical Corporation | GEI |
| Jul 20, 2012 | K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) Bovie Medical Corporation | HQP |
| Jan 27, 2012 | K112233 | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE Bovie Medical Corporation | GEI |
| Mar 18, 2010 | K092149 | BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 Bovie Medical | GEI |
| Mar 10, 2010 | K092383 | BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 Bovie Medical Corporation | GEI |
| Dec 22, 2009 | K093025 | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES Bovie Medical Corporation | GEI |
| Oct 9, 2009 | K091440 | LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L Bovie Medical | GEI |
| Aug 7, 2009 | K090586 | BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) Bovie Medical | GEI |
| Nov 17, 2008 | K082568 | SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE Bovie Medical | GEI |
| Oct 2, 2008 | K082109 | BOVIE ICON GENERAL PURPOSE RF GENERATOR Bovie Medical | GEI |
| Jul 24, 2008 | K081431 | MEG LAPAROSCOPIC ELECTRODES Bovie Medical | GEI |
| Apr 10, 2008 | K072041 | BOVIE IDS-400 ELECTROSURGICAL GENERATOR Bovie Medical | GEI |
| Sep 6, 2006 | K061884 | BOVIE ICON GI ELECTROSURGICAL GENERATOR, MODEL GI 120 Bovie Medical | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K152777 K161558 |
| 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 | K161558 |
| 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 | K152777 K161558 |
| Apr 20, 2020 | Bovie Medical Corporation Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS.
Product Usage: for el Terminated |
GEI | K151325 K183160 |
| 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 | K170188 K183610 |
| 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 | K152570 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF Terminated |
GEI | K170188 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR Terminated |
GEI | K170188 |
| Feb 8, 2018 | Bovie Medical Corporation J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B Terminated |
GEI | K170188 |
| 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 | K170188 |
| 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 | K170188 |
| 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 | K152570 |
| 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 | K152570 |
| 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 | K152570 |
| 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 | K152570 |