Cleared Special

K012116 - ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING

K012116 · Acrymed, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
68d
Days
-
Risk

K012116 is an FDA 510(k) clearance for the ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acrymed, Inc. (Portland, US). The FDA issued a Cleared decision on September 12, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Acrymed, Inc. devices

FDA 510(k) Submission Details - K012116

510(k) Number K012116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date September 12, 2001
Days to Decision 68 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 607
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K012116.
ABSORBENT ANTIMICROBIAL WOUND DRESSING
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HYDROFERA BACTERIOSTATIC WOUND DRESSING
K013462 · Hydrofera, LLC · Jan 2002
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K011941 · The Kendall Company · Aug 2001
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K010951 · Island Dressing, LLC · Jun 2001
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K004028 · Maersk Medical, Ltd. · Mar 2001