Cleared Special

K070269 - MODIFICATION TO COLLAWOUND DRESSING

K070269 · Collamatrix Co., Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
32d
Days
-
Risk

K070269 is an FDA 510(k) clearance for the MODIFICATION TO COLLAWOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Collamatrix Co., Inc. (Taipei, TW). The FDA issued a Cleared decision on March 2, 2007 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070269

510(k) Number K070269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date March 02, 2007
Days to Decision 32 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

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 188
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K070269.
NOCC HYDROPHILIC WOUND DRESSING
K080010 · Kytogenics, Inc. · Mar 2008
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
UNITE BIOMATRIX
K071425 · Pegasus Biologics, Inc. · Jun 2007
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
K061746 · Innocoll Pharmaceuticals · Oct 2006
DERMADAPT WOUND DRESSING
K061494 · Pegasus Biologics, Inc. · Sep 2006
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006
K070269 · MODIFICATION TO COLLAWOUND DRESSING
Download PDF FDA Summary Collamatrix Co., Inc.