Cleared Special

K061407 - PRIMATRIX DERMAL REPAIR SCAFFOLD

K061407 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
38d
Days
-
Risk

K061407 is an FDA 510(k) clearance for the PRIMATRIX DERMAL REPAIR SCAFFOLD. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on June 29, 2006 after a review of 38 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 Tei Biosciences, Inc. devices

FDA 510(k) Submission Details - K061407

510(k) Number K061407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2006
Decision Date June 29, 2006
Days to Decision 38 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
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 96
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K061407.
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
MEDLINE COLLAGEN WOUND DRESSING
K060456 · Medline Industries, Inc. · Jun 2006
COLLAGEN WOUND DRESSING - ORAL
K040403 · Collagen Matrix, Inc. · May 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · Collagen Matrix, Inc. · Mar 2004