Cleared Traditional

K091338 - COLLASORB COLLAGEN WOUND DRESSING

K091338 · Hartmann-Conco, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2009
Decision
112d
Days
-
Risk

K091338 is an FDA 510(k) clearance for the COLLASORB COLLAGEN WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Hartmann-Conco, Inc. (Crofton, US). The FDA issued a Cleared decision on August 26, 2009 after a review of 112 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 Hartmann-Conco, Inc. devices

FDA 510(k) Submission Details - K091338

510(k) Number K091338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2009
Decision Date August 26, 2009
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 K091338.
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PRIMATRIX DERMAL REPAIR SCAFFOLD
K083440 · Tei Biosciences, Inc. · Dec 2008
INTEGRA MESHED BILAYER WOUND MATRIX
K081635 · Integra Lifesciences Corp. · Dec 2008