Cleared Traditional

K063805 - SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901

K063805 · Nucryst Pharmaceuticals, Inc. · General & Plastic Surgery device
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Jul 2007
Decision
203d
Days
-
Risk

K063805 is an FDA 510(k) clearance for the SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nucryst Pharmaceuticals, Inc. (Wakefield, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 203 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 Nucryst Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K063805

510(k) Number K063805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date July 13, 2007
Days to Decision 203 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
88d slower than avg
Panel avg: 115d · This submission: 203d
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 K063805.
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K053613 · Theo Manufacturing BV · Jul 2007
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
K063069 · Medical Molecular Therapuetics, LLC · Jul 2007
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K070581 · Advanced Medical Solutions Limited · Jul 2007
MEPILEX AG DRESSING
K071354 · Monlycke Health Care · Jul 2007
HONEY ALGINATE DRESSING
K053095 · Derma Sciences Canada, Inc. · Jul 2007