Cleared Traditional

K062212 - SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S

K062212 · Anacapa Technologies, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
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 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K062212.
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
K061554 · Molnlycke Health Care · Jan 2007
LOCOBASE WOUND AND SKIN EMULSION
K060272 · Ferndale Laboratories, Inc. · Jan 2007
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER
K061227 · The Hymed Group Corp. · Dec 2006
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING
K063173 · Advanced Medical Solutions Limited · Nov 2006
SINCLAIR SEBORRHEA EMULSION
K050158 · Sinclair Pharmaceuticals, Ltd. · Oct 2006
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER
K053538 · Curapharm, Inc. · Oct 2006