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FDA 510(k)

MODIFICATION TO ACTICOAT FOAM DRESSING

K-Number: K010447 · 2001-03-15

ApplicantWestaim Biomedical, Inc.
Decision Date2001-03-15
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ACTICOAT FOAM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Westaim Biomedical, Inc.. It received FDA 510(k) clearance on 2001-03-15 under 510(k) number K010447. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ACTICOAT FOAM DRESSING?

MODIFICATION TO ACTICOAT FOAM DRESSING is a medical device that received FDA 510(k) clearance on 2001-03-15. The listed applicant is Westaim Biomedical, Inc.. The 510(k) number is K010447.

When did MODIFICATION TO ACTICOAT FOAM DRESSING receive FDA 510(k) clearance?

MODIFICATION TO ACTICOAT FOAM DRESSING received FDA 510(k) clearance on 2001-03-15, under 510(k) number K010447.

Who is the listed applicant for MODIFICATION TO ACTICOAT FOAM DRESSING?

The FDA 510(k) record lists Westaim Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO ACTICOAT FOAM DRESSING?

The FDA product code for MODIFICATION TO ACTICOAT FOAM DRESSING is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Westaim Biomedical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K002466ACTICOAT COMPOSITE DRESSINGK001519ACTICOAT 7 DRESSINGK992221ACTICOAT PRIMARY ANTIMICROBIAL DRESSINGK000051ACTICOAT FOAM DRESSINGK983833ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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