Cleared Traditional

K063835 - ALLEVYN AG DRESSING

K063835 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
220d
Days
-
Risk

K063835 is an FDA 510(k) clearance for the ALLEVYN AG DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Smith & Nephew, Inc. (Largo, US). The FDA issued a Cleared decision on August 3, 2007 after a review of 220 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.

FDA 510(k) Submission Details - K063835

510(k) Number K063835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2006
Decision Date August 03, 2007
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063835.
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
K070685 · Tyco Healthcare · Sep 2007
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ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
K071703 · Swiss American Products, Inc. · Aug 2007
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
K053613 · Theo Manufacturing BV · Jul 2007
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
K063069 · Medical Molecular Therapuetics, LLC · Jul 2007
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
K063805 · Nucryst Pharmaceuticals, Inc. · Jul 2007
K063835 · ALLEVYN AG DRESSING
Download PDF FDA Summary Smith & Nephew, Inc.