Cleared Abbreviated

K093351 - COLLAWOUND ART

K093351 · Collamatrix, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
232d
Days
-
Risk

K093351 is an FDA 510(k) clearance for the COLLAWOUND ART. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Collamatrix, Inc. (Taipei, TW). The FDA issued a Cleared decision on June 16, 2010 after a review of 232 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K093351

510(k) Number K093351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2009
Decision Date June 16, 2010
Days to Decision 232 days
Submission Type Abbreviated
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
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K093351.
PRUCLAIR NONSTEROIDAL CREAM
K093156 · Prugen IP Holdings, Inc. · Jun 2010
PR CREAM
K093159 · Prugen IP Holdings, Inc. · Jun 2010
DRYODINE CADEXOMER-IODINE GEL
K093320 · Collegium Pharmaceutical Incorporated · Jun 2010
URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100429 · Laboratoires Urgo · Jun 2010
URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER
K100430 · Laboratoires Urgo · Jun 2010
MANUKAPLI WOUND DRESSING
K092689 · Manuka Medical Limited · May 2010
K093351 · COLLAWOUND ART
Download PDF FDA Summary Collamatrix, Inc.