Cleared Traditional

K063271 - AQUACEL HYDROFIBER DRESSING AND AQUACEL...

K063271 · Convatec, A Division of E.R. Squibb & Sons, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
168d
Days
-
Risk

K063271 is an FDA 510(k) clearance for the AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons, LLC (Skillman, US). The FDA issued a Cleared decision on April 16, 2007 after a review of 168 days - an extended review cycle.

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 Convatec, A Division of E.R. Squibb & Sons, LLC devices

Submission Details

510(k) Number K063271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2006
Decision Date April 16, 2007
Days to Decision 168 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
53d slower than avg
Panel avg: 115d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 223
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063271.
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K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
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K063458 · 3M Company · Apr 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
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K052720 · Medline Industries, Inc. · Oct 2005