Cleared Traditional

K063069 - SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION

K063069 · Medical Molecular Therapuetics, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
280d
Days
-
Risk

K063069 is an FDA 510(k) clearance for the SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medical Molecular Therapuetics, LLC (Lakemont, US). The FDA issued a Cleared decision on July 13, 2007 after a review of 280 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 - K063069

510(k) Number K063069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2006
Decision Date July 13, 2007
Days to Decision 280 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
165d slower than avg
Panel avg: 115d · This submission: 280d
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 708
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K063069.
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
K071703 · Swiss American Products, Inc. · Aug 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE
K053613 · Theo Manufacturing BV · Jul 2007
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901
K063805 · Nucryst Pharmaceuticals, Inc. · Jul 2007
SILVER ALGINATE II WOUND DRESSING
K070581 · Advanced Medical Solutions Limited · Jul 2007
MEPILEX AG DRESSING
K071354 · Monlycke Health Care · Jul 2007
K063069 · SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION
Download PDF FDA Summary Medical Molecular The…