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FDA 510(k)

FORTADERM WOUND DRESSING

K-Number: K011026 · 2001-06-13

ApplicantOrganogenesis, Inc.
Decision Date2001-06-13
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

FORTADERM 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 2001-06-13 under 510(k) number K011026. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTADERM WOUND DRESSING?

FORTADERM WOUND DRESSING is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Organogenesis, Inc.. The 510(k) number is K011026.

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

FORTADERM WOUND DRESSING received FDA 510(k) clearance on 2001-06-13, under 510(k) number K011026.

Who is the listed applicant for FORTADERM 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 WOUND DRESSING?

The FDA product code for FORTADERM WOUND DRESSING is KGN.

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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 MEMBRANEK051647FORTADERM ANTIMICROBIAL WOUND DRESSINGK042809CUFFPATCHK021107FORTAFLEX SURGICAL SLING

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Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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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