Cleared Traditional

K162759 - KeraStat Gel

K162759 · Keranetics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
245d
Days
-
Risk

K162759 is an FDA 510(k) clearance for the KeraStat(R) Gel. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Keranetics, LLC (Winston-Salem, US). The FDA issued a Cleared decision on June 2, 2017 after a review of 245 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 Keranetics, LLC devices

FDA 510(k) Submission Details - K162759

510(k) Number K162759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date June 02, 2017
Days to Decision 245 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
130d slower than avg
Panel avg: 115d · This submission: 245d
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 K162759.
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MicroMatrix
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Collagen Dental Wound Dressings
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MicroMatrix
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Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015