FDA 510(k)

BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR

K-Number: K910663 · 1991-05-09

Decision Date1991-05-09

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mdt Corp., Inc.. It received FDA 510(k) clearance on 1991-05-09 under 510(k) number K910663. 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 MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR?

BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR is a medical device that received FDA 510(k) clearance on 1991-05-09. The listed applicant is Mdt Corp., Inc.. The 510(k) number is K910663.

When did BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR receive FDA 510(k) clearance?

BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR received FDA 510(k) clearance on 1991-05-09, under 510(k) number K910663.

Who is the listed applicant for BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR?

The FDA 510(k) record lists Mdt Corp., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR?

The FDA product code for BOVIE MODEL X-10, X-10I, ELECTROSURGICAL 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.