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FDA 510(k)

FORTADERM ANTIMICROBIAL WOUND DRESSING

K-Number: K051647 · 2005-11-08

ApplicantOrganogenesis, Inc.
Decision Date2005-11-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

FORTADERM ANTIMICROBIAL WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Organogenesis, Inc.. It received FDA 510(k) clearance on 2005-11-08 under 510(k) number K051647. 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 FORTADERM ANTIMICROBIAL WOUND DRESSING?

FORTADERM ANTIMICROBIAL WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2005-11-08. The listed applicant is Organogenesis, Inc.. The 510(k) number is K051647.

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

FORTADERM ANTIMICROBIAL WOUND DRESSING received FDA 510(k) clearance on 2005-11-08, under 510(k) number K051647.

Who is the listed applicant for FORTADERM ANTIMICROBIAL WOUND DRESSING?

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

What is the FDA product code for FORTADERM ANTIMICROBIAL WOUND DRESSING?

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

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Other records listing Organogenesis, 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.

K212579FortiShield (Biosynthetic Wound Matrix)K220317PuraPly Micronized Wound Matrix (PuraPly MZ)K071555FORTAGEN ORAL MEMBRANEK042809CUFFPATCHK021107FORTAFLEX SURGICAL SLINGK021105FORTAFLEX SURGICAL MESH

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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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