Cleared Traditional

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (K091013) - FDA 510(k) Clearance

K091013 · Advanced Medical Solutions Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
112d
Days
-
Risk

K091013 is an FDA 510(k) clearance for the SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on July 30, 2009 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 Advanced Medical Solutions Limited devices

Submission Details

510(k) Number K091013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2009
Decision Date July 30, 2009
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.

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 K091013.
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MEDLINE CURAD WOUND DRESSINGS
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ACTICOAT FLEX 7 DRESSING
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PROWICK
K083007 · Arthrex, Inc. · Apr 2009
PRONTOSAN ANTIMICROBIAL WOUND GEL
K090141 · B.Braun Medical, Inc. · Mar 2009