Cleared Special

K010447 - MODIFICATION TO ACTICOAT FOAM DRESSING

K010447 · Westaim Biomedical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
30d
Days
-
Risk

K010447 is an FDA 510(k) clearance for the MODIFICATION TO ACTICOAT FOAM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Westaim Biomedical, Inc. (Exeter, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 30 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 Westaim Biomedical, Inc. devices

FDA 510(k) Submission Details - K010447

510(k) Number K010447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2001
Decision Date March 15, 2001
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
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 K010447.
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K004028 · Maersk Medical, Ltd. · Mar 2001
ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
K002896 · The Westaim Corp. · Feb 2001
ACTICOAT COMPOSITE DRESSING
K002466 · Westaim Biomedical, Inc. · Feb 2001
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
K002909 · Acrymed, Inc. · Oct 2000