Cleared Traditional

K081724 - HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL

K081724 · Applied Nutritionals · General & Plastic Surgery device
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Oct 2008
Decision
134d
Days
-
Risk

K081724 is an FDA 510(k) clearance for the HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSA.... Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Applied Nutritionals (Bethlehem, US). The FDA issued a Cleared decision on October 30, 2008 after a review of 134 days - within the typical 510(k) review window.

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 Applied Nutritionals devices

FDA 510(k) Submission Details - K081724

510(k) Number K081724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2008
Decision Date October 30, 2008
Days to Decision 134 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
19d slower than avg
Panel avg: 115d · This submission: 134d
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 119
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K081724.
ATLAS WOUND MATRIX
K090954 · Wrightmedicaltechnologyinc · Jul 2009
PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · Tei Biosciences, Inc. · Dec 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006
PRIMATRIX DERMAL REPAIR SCAFFOLD
K061407 · Tei Biosciences, Inc. · Jun 2006