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Bovie Medical Corporation

FDA Regulatory Profile

Summary

Total Recalls
15
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1155-2021Class IIConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, aFebruary 1, 2021
Z-1153-2021Class IIVelocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization,February 1, 2021
Z-1154-2021Class IIHNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and February 1, 2021
Z-2061-2020Class IIRenuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVApril 20, 2020
Z-2060-2020Class IIRenuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BApril 20, 2020
Z-0198-2019Class IIJ-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used fJune 18, 2018
Z-1153-2018Class IIJ-Plasma Precise(R) OPEN, Catalog Numbers: BVX-044-BPP, BVX-044-BPS, BVX-150-BPP, BVX-150-BPSFebruary 8, 2018
Z-1154-2018Class IIJ-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450NFebruary 8, 2018
Z-1156-2018Class IIJ-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NRFebruary 8, 2018
Z-1155-2018Class IIJ-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270BFebruary 8, 2018
Z-1157-2018Class IIJ-Plasma Precise(R) FLEX, Catalog Number: BVX-500BFFebruary 8, 2018
Z-2647-2016Class IIBVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gJuly 18, 2016
Z-2649-2016Class IIBVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gJuly 18, 2016
Z-2646-2016Class IIBVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gaJuly 18, 2016
Z-2648-2016Class IIBVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas July 18, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma PrMarch 12, 2019
K170777Bovie J-Plasma Precise FLEX HandpieceMay 1, 2017
K170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratoMarch 8, 2017
K161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable BiJuly 29, 2016
K161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942June 20, 2016
K152777Bovie Disposable Bipolar AblatorJanuary 15, 2016
K152570Bovie J-Plasma Precise 360 HandpieceNovember 2, 2015
K151325Bovie J-Plasma HandpieceAugust 4, 2015
K142975Bovie Ultimate High Frequency Electrosurgical GeneratorDecember 12, 2014
K134054BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GMarch 17, 2014
K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)July 20, 2012
K112233BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADEJanuary 27, 2012
K092383BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300March 10, 2010
K093025BOVIE RESISTICK II COATED ELECTROSURGICAL ELECTRODESDecember 22, 2009