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FDA 510(k)

ATRAUM WOUND DRESSING

K-Number: K852614 · 1985-08-30

ApplicantAxiom Medical, Inc.
Decision Date1985-08-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ATRAUM WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1985-08-30 under 510(k) number K852614. 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 ATRAUM WOUND DRESSING?

ATRAUM WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1985-08-30. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K852614.

When did ATRAUM WOUND DRESSING receive FDA 510(k) clearance?

ATRAUM WOUND DRESSING received FDA 510(k) clearance on 1985-08-30, under 510(k) number K852614.

Who is the listed applicant for ATRAUM WOUND DRESSING?

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

What is the FDA product code for ATRAUM WOUND DRESSING?

The FDA product code for ATRAUM WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Axiom Medical, 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.

K993592AXIOM MULTIPURPOSE WOUND DRAINK971851INTERPLEURAL ANESTHESIA CATHETERK965146FLAT CLOSED WOUND DRAIN WITH TROCARK934895GLASSMAN SILICONE CATHETERK922760ATRAUM WOUND DRESSING--MODIFICATIONK905422PVC ROUND WOUND DRAINS

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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

View on FDA Database →

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

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