Cleared Traditional

K080503 - SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING

K080503 · Advanced Medical Solutions Limited · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Nov 2008
Decision
261d
Days
-
Risk

K080503 is an FDA 510(k) clearance for the SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions Limited (Winsford, Cheshire, GB). The FDA issued a Cleared decision on November 12, 2008 after a review of 261 days - an extended review cycle.

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 - K080503

510(k) Number K080503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date November 12, 2008
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
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 K080503.
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PROSIT WOUND TREATMENT DEVICE
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PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION
K082330 · Primary Care Solutions, Inc. · Oct 2008
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
K081363 · Advanced Medical Solutions Limited · Sep 2008
ACRYDERM ABSORBENT OXYGEN DRESSING
K082459 · Acrymed, Inc. · Sep 2008