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FDA 510(k)

Gynescope System

K-Number: K190187 · 2019-05-08

ApplicantIllumigyn , Ltd.
Decision Date2019-05-08
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Gynescope System is a medical device manufactured by Illumigyn , Ltd.. It received FDA 510(k) clearance on 2019-05-08 under approval number K190187. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gynescope System?

Gynescope System is a medical device that received FDA 510(k) clearance on 2019-05-08. It is manufactured by Illumigyn , Ltd.. The 510(k) number is K190187.

When was Gynescope System approved by the FDA?

Gynescope System received FDA 510(k) clearance on 2019-05-08, under approval number K190187.

What company makes Gynescope System?

Gynescope System is manufactured by Illumigyn , Ltd..

What is the FDA product code for Gynescope System?

The FDA product code for Gynescope System is HEX.

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Official Source

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

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