Cleared Special

K071425 - UNITE BIOMATRIX

K071425 · Pegasus Biologics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
28d
Days
-
Risk

K071425 is an FDA 510(k) clearance for the UNITE BIOMATRIX. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Pegasus Biologics, Inc. (Irvine, US). The FDA issued a Cleared decision on June 20, 2007 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.

FDA 510(k) Submission Details - K071425

510(k) Number K071425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2007
Decision Date June 20, 2007
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
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 188
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K071425.
COLLIEVA
K081782 · Innocoll Pharmaceuticals · Sep 2008
NOCC HYDROPHILIC WOUND DRESSING
K080010 · Kytogenics, Inc. · Mar 2008
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
K072113 · Integra Lifesciences Corp. · Oct 2007
MODIFICATION TO COLLAWOUND DRESSING
K070269 · Collamatrix Co., Inc. · Mar 2007
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID
K061746 · Innocoll Pharmaceuticals · Oct 2006
DERMADAPT WOUND DRESSING
K061494 · Pegasus Biologics, Inc. · Sep 2006
K071425 · UNITE BIOMATRIX
Download PDF FDA Summary Pegasus Biologics, In…