Cleared Traditional

K052696 - COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING

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
PCCP Authorized No
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K052696.
DERMACYN WOUND CARE
K060113 · Oculus Innovative Sciences, Inc. · Feb 2006
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
K050086 · Brennen Medical, Inc. · Feb 2006
SUCRALFATE AND CARAFATE PASTE KITS
K043587 · Patrick D. Mcgrath Ph.D · Feb 2006
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
SILVERSEAL SILVERAID WITH X-STATIC
K050726 · Noble Fiber Technologies, Inc. · Dec 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
K051647 · Organogenesis, Inc. · Nov 2005