Cleared Traditional

K172010 - gel-e Bandage

K172010 · Gel-E, Inc. (Formerly Remedium Technologies, Inc.) · General & Plastic Surgery device
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Dec 2017
Decision
157d
Days
-
Risk

K172010 is an FDA 510(k) clearance for the gel-e Bandage. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Gel-E, Inc. (Formerly Remedium Technologies, Inc.) (College Park, US). The FDA issued a Cleared decision on December 7, 2017 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gel-E, Inc. (Formerly Remedium Technologies, Inc.) devices

FDA 510(k) Submission Details - K172010

510(k) Number K172010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date December 07, 2017
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 105
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K172010.
Cytal Wound Particulate
K180776 · Acell, Inc. · May 2018
XCelliStem Wound Powder
K172593 · Stemsys · Mar 2018
ologen Collagen Matrix
K173223 · Aeon Astron Europe B.V. · Mar 2018
Geistlich Wound Matrix
K171842 · Geistlich Pharma AG · Nov 2017
MicroMatrix
K172399 · Acell, Inc. · Oct 2017
Collagen Dental Wound Dressings
K152600 · Collagen Matrix, Inc. · Jun 2016