EndyGel

FDA 510(k) K161715 · Endymed Medical, Ltd.

Substantially Equivalent

510(k) numberK161715

Submission

Device name
EndyGel
Applicant
Endymed Medical, Ltd.
Caesarea, IL
Received
June 21, 2016
Decision date
February 7, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GYB – Media, Electroconductive
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1275
Specialty
Neurology

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Questions and answers

When was EndyGel cleared by the FDA?

EndyGel (K161715) received a 510(k) decision of Substantially Equivalent on February 7, 2017, 231 days after the submission was received.

What is the product code of K161715?

The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.