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FDA 510(k)

Foundation Dermal Regeneration Scaffold (DRS) Solo

K-Number: K210949 · 2022-08-11

ApplicantBionova Medical, Inc.
Decision Date2022-08-11
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Foundation Dermal Regeneration Scaffold (DRS) Solo is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K210949. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Foundation Dermal Regeneration Scaffold (DRS) Solo?

Foundation Dermal Regeneration Scaffold (DRS) Solo is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K210949.

When did Foundation Dermal Regeneration Scaffold (DRS) Solo receive FDA 510(k) clearance?

Foundation Dermal Regeneration Scaffold (DRS) Solo received FDA 510(k) clearance on 2022-08-11, under 510(k) number K210949.

Who is the listed applicant for Foundation Dermal Regeneration Scaffold (DRS) Solo?

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

What is the FDA product code for Foundation Dermal Regeneration Scaffold (DRS) Solo?

The FDA product code for Foundation Dermal Regeneration Scaffold (DRS) Solo is KGN.

Other records listing Bionova Medical, 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.

K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloK240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoK231937Foundation Dermal Regeneration Scaffold (DRS) Solo

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.

K260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, Inc.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.

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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