Bovie Medical Corporation
FDA Regulatory Profile
Bovie Medical Corporation appears in FDA public data with 15 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1155-2021, Class II) was initiated on February 1, 2021. Its most recent 510(k) clearance was granted on March 12, 2019.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1155-2021 | Class II | ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, a | February 1, 2021 |
| Z-1153-2021 | Class II | Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, | February 1, 2021 |
| Z-1154-2021 | Class II | HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and | February 1, 2021 |
| Z-2061-2020 | Class II | Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BV | April 20, 2020 |
| Z-2060-2020 | Class II | Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, B | April 20, 2020 |
| Z-0198-2019 | Class II | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used f | June 18, 2018 |
| Z-1154-2018 | Class II | J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N | February 8, 2018 |
| Z-1153-2018 | Class II | J-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPS | February 8, 2018 |
| Z-1157-2018 | Class II | J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF | February 8, 2018 |
| Z-1156-2018 | Class II | J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR | February 8, 2018 |
| Z-1155-2018 | Class II | J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B | February 8, 2018 |
| Z-2646-2016 | Class II | BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium ga | July 18, 2016 |
| Z-2649-2016 | Class II | BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium g | July 18, 2016 |
| Z-2648-2016 | Class II | BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas | July 18, 2016 |
| Z-2647-2016 | Class II | BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium g | July 18, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Pr | March 12, 2019 |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | May 1, 2017 |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generato | March 8, 2017 |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bi | July 29, 2016 |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 | June 20, 2016 |
| K152777 | Bovie Disposable Bipolar Ablator | January 15, 2016 |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | November 2, 2015 |
| K151325 | Bovie J-Plasma Handpiece | August 4, 2015 |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | December 12, 2014 |
| K134054 | BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL G | March 17, 2014 |
| K121441 | CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) | July 20, 2012 |
| K112233 | BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE | January 27, 2012 |
| K092383 | BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 | March 10, 2010 |
| K093025 | BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODES | December 22, 2009 |