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FDA 510(k)

Catalyze

K-Number: K253204 · 2026-06-05

ApplicantBioTissue Holdings, Inc.
Decision Date2026-06-05
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

Catalyze is the device name listed in this FDA 510(k) record. The listed applicant is BioTissue Holdings, Inc.. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K253204. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Catalyze?

Catalyze is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is BioTissue Holdings, Inc.. The 510(k) number is K253204.

When did Catalyze receive FDA 510(k) clearance?

Catalyze received FDA 510(k) clearance on 2026-06-05, under 510(k) number K253204.

Who is the listed applicant for Catalyze?

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

What is the FDA product code for Catalyze?

The FDA product code for Catalyze 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.K254034Roosin Collagen PowderRoosin Medical Co., Ltd.K253974Roosin Collagen DressingRoosin Medical Co., Ltd.K261224MatriDermMedskin Solutions Dr. Suwelack AG

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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