Cleared Traditional

K062212 - SILVER SHIELD ANTIMICROBIAL SKIN AND WO...

K062212 · Anacapa Technologies, Inc. · General & Plastic Surgery device
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Nov 2006
Decision
112d
Days
-
Risk

K062212 is an FDA 510(k) clearance for the SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Anacapa Technologies, Inc. (San Dimas, US). The FDA issued a Cleared decision on November 21, 2006 after a review of 112 days - within the typical 510(k) review window.

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 Anacapa Technologies, Inc. devices

FDA 510(k) Submission Details - K062212

510(k) Number K062212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2006
Decision Date November 21, 2006
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K062212.
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007
ALLEVYN AG DRESSING
K063835 · Smith & Nephew, Inc. · Aug 2007
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005