Cleared Traditional

K052696 - COVACLEARAG COLLAGEN WITH SILVER ANTIMI...

K052696 · Covalon Technologies, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2006
Decision
128d
Days
-
Risk

K052696 is an FDA 510(k) clearance for the COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covalon Technologies, Ltd. (Waxhaw, US). The FDA issued a Cleared decision on February 3, 2006 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Covalon Technologies, Ltd. devices

FDA 510(k) Submission Details - K052696

510(k) Number K052696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2005
Decision Date February 03, 2006
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K052696.
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005