Cleared Special

K083440 - PRIMATRIX DERMAL REPAIR SCAFFOLD

K083440 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
22d
Days
-
Risk

K083440 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 December 12, 2008 after a review of 22 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 - K083440

510(k) Number K083440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2008
Decision Date December 12, 2008
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 K083440.
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INTEGRA MESHED BILAYER WOUND MATRIX
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K072113 · Integra Lifesciences Corp. · Oct 2007
OASIS WOUND MATRIX
K061711 · Cook Biotech, Inc. · Jul 2006