Cleared Traditional

K061232 - ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006

K061232 · Acrymed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
157d
Days
-
Risk

K061232 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 157 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 - K061232

510(k) Number K061232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date October 06, 2006
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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 607
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