MODIFICATION TO ACTICOAT FOAM DRESSING— 510(k) K010447

Name: FDA 510(k) clearance K010447
Creator: U.S. Food and Drug Administration
Published: 2001-03-15

Substantially Equivalent

Westaim Biomedical, Inc.

FDA 510(k) clearance K010447 for MODIFICATION TO ACTICOAT FOAM DRESSING, Substantially Equivalent on 2001-03-15. Applicant: Westaim Biomedical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Westaim Biomedical, Inc.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2001-02-13
Decision date: 2001-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Exeter, NH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Westaim Biomedical, Inc.

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K002466 — ACTICOAT COMPOSITE DRESSING2001-02-16
K001519 — ACTICOAT 7 DRESSING2000-10-06
K992221 — ACTICOAT PRIMARY ANTIMICROBIAL DRESSING2000-06-07
K000051 — ACTICOAT FOAM DRESSING2000-04-05
K983833 — ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE1998-12-10

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.