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FDA 510(k)

DUODERM HYDROACTIVE DRESSING

K-Number: K973689 · 1997-12-23

ApplicantConvatec, Ltd.
Decision Date1997-12-23
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

DUODERM HYDROACTIVE DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, Ltd.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K973689. 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 DUODERM HYDROACTIVE DRESSING?

DUODERM HYDROACTIVE DRESSING is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Convatec, Ltd.. The 510(k) number is K973689.

When did DUODERM HYDROACTIVE DRESSING receive FDA 510(k) clearance?

DUODERM HYDROACTIVE DRESSING received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973689.

Who is the listed applicant for DUODERM HYDROACTIVE DRESSING?

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

What is the FDA product code for DUODERM HYDROACTIVE DRESSING?

The FDA product code for DUODERM HYDROACTIVE 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 Convatec, Ltd. 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.

K973688DUODERM CONTROL GEL FORMULA BORDER DRESSING

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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