Cleared Traditional

K070333 - ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL

K070333 · Acrymed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
155d
Days
-
Risk

K070333 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Beaverton, US). The FDA issued a Cleared decision on July 10, 2007 after a review of 155 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 - K070333

510(k) Number K070333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2007
Decision Date July 10, 2007
Days to Decision 155 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
40d slower than avg
Panel avg: 115d · This submission: 155d
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
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K070333.
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