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FDA 510(k)

EndyGel

K-Number: K161715 · 2017-02-07

ApplicantEndymed Medical, Ltd.
Decision Date2017-02-07
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EndyGel is a medical device manufactured by Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2017-02-07 under approval number K161715. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndyGel?

EndyGel is a medical device that received FDA 510(k) clearance on 2017-02-07. It is manufactured by Endymed Medical, Ltd.. The 510(k) number is K161715.

When was EndyGel approved by the FDA?

EndyGel received FDA 510(k) clearance on 2017-02-07, under approval number K161715.

What company makes EndyGel?

EndyGel is manufactured by Endymed Medical, Ltd..

What is the FDA product code for EndyGel?

The FDA product code for EndyGel is GYB.

Other Devices by Endymed Medical, Ltd.

K161199EndyMed Contour Handpiece K222369PURE Laser K242996EndyMed PRO MAX

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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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