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FDA 510(k)

RUBYCELL(TM) SYNTHETIC ISLAND DRESSING

K-Number: K870352 · 1987-02-26

ApplicantBioderm, Inc.
Decision Date1987-02-26
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

RUBYCELL(TM) SYNTHETIC ISLAND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Bioderm, Inc.. It received FDA 510(k) clearance on 1987-02-26 under 510(k) number K870352. 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 RUBYCELL(TM) SYNTHETIC ISLAND DRESSING?

RUBYCELL(TM) SYNTHETIC ISLAND DRESSING is a medical device that received FDA 510(k) clearance on 1987-02-26. The listed applicant is Bioderm, Inc.. The 510(k) number is K870352.

When did RUBYCELL(TM) SYNTHETIC ISLAND DRESSING receive FDA 510(k) clearance?

RUBYCELL(TM) SYNTHETIC ISLAND DRESSING received FDA 510(k) clearance on 1987-02-26, under 510(k) number K870352.

Who is the listed applicant for RUBYCELL(TM) SYNTHETIC ISLAND DRESSING?

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

What is the FDA product code for RUBYCELL(TM) SYNTHETIC ISLAND DRESSING?

The FDA product code for RUBYCELL(TM) SYNTHETIC ISLAND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Bioderm, 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.

K990955MODIFICATION OF:BIODERM FOAM WOUND DRESSINGK982778BIODERM FOAM WOUND DRESSINGK982939BTF THIN FILM WOUND DRESSINGK980451BIODERM CALCIUM ALGINATE DRESSINGK973429BIODERM FOAM WOUND DRESSINGK963950BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE

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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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