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Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator

by Bovie Medical Corporation

510(k) K170188

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170188 Date8 Mar 2017ClearedStatusActive

Recalls

6 recalls · FDA

    • Terminated Z-2060-2020 FDA Class II initiated 20 Apr 2020

    Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

  • 5 recalls, same reason

    • Terminated Z-1153-2018 FDA Class II initiated 8 Feb 2018
    • Terminated Z-1154-2018 FDA Class II initiated 8 Feb 2018
    • Terminated Z-1157-2018 FDA Class II initiated 8 Feb 2018
    • Terminated Z-1156-2018 FDA Class II initiated 8 Feb 2018
    • Terminated Z-1155-2018 FDA Class II initiated 8 Feb 2018

    Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an incomplete helium seal. The potential exists for patient fluid backflow into the handpiece and the generator receptacle leading to risk of cross-contamination if the generator is reused.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bovie J-Plasma Precise Open handpiece and Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator is a medical device system designed for the delivery of radiofrequency energy and helium gas plasma. It is intended for electrosurgical cutting, coagulation, and ablation of soft tissue during open surgical procedures.

This device is supplied by Bovie Medical Corporation and received FDA 510(k) clearance under K170188 on March 8, 2017. It is intended for use in conjunction with the specified generator to perform surgical tasks.

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