Cleared Traditional

K063063 - SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION

K063063 · 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
270d
Days
-
Risk

K063063 is an FDA 510(k) clearance for the SILVACIDE SKIN & WOUND MOISTURIZING 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 3, 2007 after a review of 270 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 - K063063

510(k) Number K063063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2006
Decision Date July 03, 2007
Days to Decision 270 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
155d slower than avg
Panel avg: 115d · This submission: 270d
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 K063063.
MEPILEX AG DRESSING
K071354 · Monlycke Health Care · Jul 2007
HONEY ALGINATE DRESSING
K053095 · Derma Sciences Canada, Inc. · Jul 2007
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL
K070333 · Acrymed, Inc. · Jul 2007
MP 719
K070557 · Marine Polymer Technologies, Inc. · May 2007
SORBACT WOUND DRESSING
K063059 · Abigo Medical AB · Apr 2007
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
K063271 · Convatec, A Division of E.R. Squibb & Sons, LLC · Apr 2007
K063063 · SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION
Download PDF FDA Summary Medical Molecular The…