FDA 510(k)

EndyGel

K-Number: K161715 · 2017-02-07

Decision Date2017-02-07

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EndyGel is the device name listed in this FDA 510(k) record. The listed applicant is Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2017-02-07 under 510(k) 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. The listed applicant is Endymed Medical, Ltd.. The 510(k) number is K161715.

When did EndyGel receive FDA 510(k) clearance?

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

Who is the listed applicant for EndyGel?

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

What is the FDA product code for EndyGel?

The FDA product code for EndyGel is GYB.

Other records listing Endymed Medical, Ltd. 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.

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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.