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FDA 510(k)

scaffolene CL100 Bioresorbable Collagen Matrix

K-Number: K192346 · 2020-02-28

ApplicantFreudenberg Technology Innovation SE & Co. KG
Decision Date2020-02-28
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

scaffolene CL100 Bioresorbable Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Technology Innovation SE & Co. KG. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K192346. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the scaffolene CL100 Bioresorbable Collagen Matrix?

scaffolene CL100 Bioresorbable Collagen Matrix is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Freudenberg Technology Innovation SE & Co. KG. The 510(k) number is K192346.

When did scaffolene CL100 Bioresorbable Collagen Matrix receive FDA 510(k) clearance?

scaffolene CL100 Bioresorbable Collagen Matrix received FDA 510(k) clearance on 2020-02-28, under 510(k) number K192346.

Who is the listed applicant for scaffolene CL100 Bioresorbable Collagen Matrix?

The FDA 510(k) record lists Freudenberg Technology Innovation SE & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for scaffolene CL100 Bioresorbable Collagen Matrix?

The FDA product code for scaffolene CL100 Bioresorbable Collagen Matrix is KGN.

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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