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FDA 510(k)

Bovie J-Plasma Precise FLEX Handpiece

K-Number: K170777 · 2017-05-01

ApplicantBovie Medical Corporation
Decision Date2017-05-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bovie J-Plasma Precise FLEX Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical Corporation. It received FDA 510(k) clearance on 2017-05-01 under 510(k) number K170777. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bovie J-Plasma Precise FLEX Handpiece?

Bovie J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2017-05-01. The listed applicant is Bovie Medical Corporation. The 510(k) number is K170777.

When did Bovie J-Plasma Precise FLEX Handpiece receive FDA 510(k) clearance?

Bovie J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2017-05-01, under 510(k) number K170777.

Who is the listed applicant for Bovie J-Plasma Precise FLEX Handpiece?

The FDA 510(k) record lists Bovie Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bovie J-Plasma Precise FLEX Handpiece?

The FDA product code for Bovie J-Plasma Precise FLEX Handpiece is GEI.

Other records listing Bovie Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183610Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpiecesK180211FreezpointK170188Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical GeneratorK161558Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-AspiratingK161134Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical GeneratorK152777Bovie Disposable Bipolar Ablator

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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