Cleared Abbreviated

K023778 - DRESSSKIN

K023778 · Tei Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
321d
Days
-
Risk

K023778 is an FDA 510(k) clearance for the DRESSSKIN. 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 September 29, 2003 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tei Biosciences, Inc. devices

FDA 510(k) Submission Details - K023778

510(k) Number K023778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2002
Decision Date September 29, 2003
Days to Decision 321 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 115d · This submission: 321d
Pathway characteristics
Standards-based clearance path.

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 K023778.
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MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · Collagen Matrix, Inc. · Feb 2004
COLLAGEN TOPICAL WOUND DRESSING
K030921 · Collagen Matrix, Inc. · May 2003
AVAGEN WOUND DRESSING
K022127 · Integra Lifesciences Corp. · Sep 2002
BILAYER MATRIX WOUND DRESSING
K021792 · Integra Lifesciences Corp. · Aug 2002