FDA 510(k)

BOVIE ICON GENERAL PURPOSE RF GENERATOR

K-Number: K082109 · 2008-10-02

Decision Date2008-10-02

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BOVIE ICON GENERAL PURPOSE RF GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Bovie Medical. It received FDA 510(k) clearance on 2008-10-02 under 510(k) number K082109. 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 ICON GENERAL PURPOSE RF GENERATOR?

BOVIE ICON GENERAL PURPOSE RF GENERATOR is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Bovie Medical. The 510(k) number is K082109.

When did BOVIE ICON GENERAL PURPOSE RF GENERATOR receive FDA 510(k) clearance?

BOVIE ICON GENERAL PURPOSE RF GENERATOR received FDA 510(k) clearance on 2008-10-02, under 510(k) number K082109.

Who is the listed applicant for BOVIE ICON GENERAL PURPOSE RF GENERATOR?

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

What is the FDA product code for BOVIE ICON GENERAL PURPOSE RF GENERATOR?

The FDA product code for BOVIE ICON GENERAL PURPOSE RF GENERATOR is GEI.

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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.