Cleared Traditional

K081363 - NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING

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

FDA 510(k) Submission Details - K081363

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
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 610
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K081363.
PROSIT WOUND TREATMENT DEVICE
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K082330 · Primary Care Solutions, Inc. · Oct 2008
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K082459 · Acrymed, Inc. · Sep 2008
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NEOSALUS
K070309 · Quinnova Pharmaceuticals · Sep 2008