Cleared Special

K152033 - Cook ECM Powder

K152033 · Cook Biotech Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
28d
Days
-
Risk

K152033 is an FDA 510(k) clearance for the Cook ECM Powder. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Cook Biotech Incorporated (West Lafayette, US). The FDA issued a Cleared decision on August 19, 2015 after a review of 28 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.

View all Cook Biotech Incorporated devices

FDA 510(k) Submission Details - K152033

510(k) Number K152033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2015
Decision Date August 19, 2015
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
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 179
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K152033.
MicroMatrix
K153754 · Acell, Inc. · Mar 2016
PriMatrix Dermal Repair Scaffold
K153690 · Tei Biosciences, Inc. · Feb 2016
Cytal Wound Matrix
K152721 · Acell, Inc. · Dec 2015
XENOMEM WOUND MATRIX
K140820 · Viscus Biologics, LLC · Jun 2015
MEDEOR MATRIX WOUND DRESSING
K141738 · Kensey Nash Corporation Dba Dsm Biomedical · Feb 2015
Wound Matrix TF
K143426 · Miromatrix Medical, Inc. · Jan 2015