Cleared Traditional

NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363) - FDA 510(k) Clearance

K081363 · Advanced Medical Solutions Limited · General & Plastic Surgery device
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Sep 2008
Decision
132d
Days
-
Risk

K081363 is an FDA 510(k) clearance for the NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICR.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on September 24, 2008 after a review of 132 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 Advanced Medical Solutions Limited devices

Submission Details

510(k) Number K081363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2008
Decision Date September 24, 2008
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K081363.
ACTICOAT FLEX 7 DRESSING
K083113 · Smith & Nephew, Inc. · Jul 2009
PROWICK
K083007 · Arthrex, Inc. · Apr 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc. · Mar 2009
PRONTOSAN WOUND IRRIGATION SOLUTION
K072876 · B.Braun Medical, Inc. · Jun 2008
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
K071552 · Medline Industries, Inc. · Apr 2008
PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626
K072378 · Arthrex, Inc. · Nov 2007