Cleared Traditional

K161715 - EndyGel

K161715 is an FDA 510(k) clearance for EndyGel, manufactured by Endymed Medical, Ltd.. The device is a Class 2 Neurology device with product code GYB cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K161715 · Endymed Medical, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
231d
Days
Class 2
Risk

K161715 is an FDA 510(k) clearance for the EndyGel. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Endymed Medical, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 7, 2017 after a review of 231 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Endymed Medical, Ltd. devices

FDA 510(k) Submission Details - K161715

510(k) Number K161715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2016
Decision Date February 07, 2017
Days to Decision 231 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 148d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYB Device Classification - Class 2, Special Controls

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GYB Media, Electroconductive

All 29
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K161715.
Elefix V Paste for EEG & EMG
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K190050 · Spes Medica Srl · Jul 2019
MEDI-TRACE DEFIB PADS
K955597 · Graphic Controls Corp. · Jul 1996
TEN-20 CONDUCTIVE PASTE GEL
K933799 · Cadwell Laboratories, Inc. · May 1994
OMNI PREP GEL
K933797 · Cadwell Laboratories, Inc. · May 1994