Cleared Traditional

K091354 - ACRYDERM SILVER ANTIMICROBIAL FOAM WOUN...

K091354 · Acrymed, Inc. · General & Plastic Surgery device
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Oct 2009
Decision
166d
Days
-
Risk

K091354 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 21, 2009 after a review of 166 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 Acrymed, Inc. devices

FDA 510(k) Submission Details - K091354

510(k) Number K091354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date October 21, 2009
Days to Decision 166 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
51d slower than avg
Panel avg: 115d · This submission: 166d
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 239
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PROWICK
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PRONTOSAN ANTIMICROBIAL WOUND GEL
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