EndyGel— 510(k) K161715

Substantially Equivalent

Endymed Medical, Ltd.

FDA 510(k) clearance K161715 for EndyGel, Substantially Equivalent on 2017-02-07. Applicant: Endymed Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Endymed Medical, Ltd.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 2016-06-21
Decision date: 2017-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYB

K243749 — Jmoon Conductive Gel2025-04-08
K220735 — Avologi Gel Primer (Model: Av25)2023-09-15
K222770 — Conductive Gel2022-12-13
K221724 — Conductive Gel2022-09-23
K212325 — EEG-acp2022-06-15

More clearances from Endymed Medical, Ltd.

K242996 — EndyMed PRO MAX2025-06-10
K222369 — PURE Laser2022-10-07
K161199 — EndyMed Contour Handpiece2016-08-01
DEN150005 — Newa Skin Therapy System2015-12-18
K130501 — INTENSIF2014-03-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.