Cleared Traditional

K002896 - ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING

K002896 · The Westaim Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
156d
Days
-
Risk

K002896 is an FDA 510(k) clearance for the ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by The Westaim Corp. (Exeter, US). The FDA issued a Cleared decision on February 21, 2001 after a review of 156 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.

FDA 510(k) Submission Details - K002896

510(k) Number K002896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2000
Decision Date February 21, 2001
Days to Decision 156 days
Submission Type Traditional
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
41d slower than avg
Panel avg: 115d · This submission: 156d
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 709
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K002896.
ISLAND WOUND DRESSING WITH MICROBAN
K010951 · Island Dressing, LLC · Jun 2001
ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING
K004028 · Maersk Medical, Ltd. · Mar 2001
MODIFICATION TO ACTICOAT FOAM DRESSING
K010447 · Westaim Biomedical, Inc. · Mar 2001
ACTICOAT COMPOSITE DRESSING
K002466 · Westaim Biomedical, Inc. · Feb 2001
ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103
K002909 · Acrymed, Inc. · Oct 2000
ACTICOAT 7 DRESSING
K001519 · Westaim Biomedical, Inc. · Oct 2000
K002896 · ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING
Download PDF FDA Summary The Westaim Corp.