510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K955453Substantially Equivalent for Some Indications

Acticoat Silver Coated Dressing

Westaim Technologies, Inc., Washington DC / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K955453 is the FDA 510(k) clearance record for ACTICOAT SILVER COATED DRESSING, a class I device, cleared for Westaim Technologies, Inc. on under FDA product code KMF (Bandage, Liquid). FDA records list one 510(k) clearance for Westaim Technologies, Inc. As of , FDA records show no recalls naming K955453.

Clearance record

Decision date
Received
(184 days to decision)
Product code
KMF Bandage, Liquid
Regulation
21 CFR 880.5090
Device class
Class I
Review panel
General Hospital
Applicant
Westaim Technologies, Inc. 555 13th St., NW, Washington DC
Third party review
No

Clearances, product code KMF

Trailing 12 months

FDA records hold no clearances under product code KMF in the trailing twelve months.

FDA records show no clearances under product code KMF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260