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FDA 510(k)

CUTINOVA(R) PLUS FOAM GELFILM

K-Number: K864913 · 1987-07-24

ApplicantBeiersdorf, Inc.
Decision Date1987-07-24
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

CUTINOVA(R) PLUS FOAM GELFILM is the device name listed in this FDA 510(k) record. The listed applicant is Beiersdorf, Inc.. It received FDA 510(k) clearance on 1987-07-24 under 510(k) number K864913. 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 for Some Indications.

Frequently Asked Questions

What is the CUTINOVA(R) PLUS FOAM GELFILM?

CUTINOVA(R) PLUS FOAM GELFILM is a medical device that received FDA 510(k) clearance on 1987-07-24. The listed applicant is Beiersdorf, Inc.. The 510(k) number is K864913.

When did CUTINOVA(R) PLUS FOAM GELFILM receive FDA 510(k) clearance?

CUTINOVA(R) PLUS FOAM GELFILM received FDA 510(k) clearance on 1987-07-24, under 510(k) number K864913.

Who is the listed applicant for CUTINOVA(R) PLUS FOAM GELFILM?

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

What is the FDA product code for CUTINOVA(R) PLUS FOAM GELFILM?

The FDA product code for CUTINOVA(R) PLUS FOAM GELFILM is FRO. This falls under the Anesthesiology category.

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Other records listing Beiersdorf, 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.

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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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