Cleared Special

K060804 - COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSING

K060804 · Covalon Technologies, Ltd. · General & Plastic Surgery device
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Apr 2006
Decision
25d
Days
-
Risk

K060804 is an FDA 510(k) clearance for the COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIA.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Covalon Technologies, Ltd. (Waxhaw, US). The FDA issued a Cleared decision on April 18, 2006 after a review of 25 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 Covalon Technologies, Ltd. devices

FDA 510(k) Submission Details - K060804

510(k) Number K060804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2006
Decision Date April 18, 2006
Days to Decision 25 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 115d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K060804.
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EPICERAM
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K060113 · Oculus Innovative Sciences, Inc. · Feb 2006