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FDA 510(k)

DermiSphere Dermal Template

K-Number: K241904 · 2025-01-06

ApplicantFesariustherapeutics, Inc.
Decision Date2025-01-06
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

DermiSphere Dermal Template is the device name listed in this FDA 510(k) record. The listed applicant is Fesariustherapeutics, Inc.. It received FDA 510(k) clearance on 2025-01-06 under 510(k) number K241904. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DermiSphere Dermal Template?

DermiSphere Dermal Template is a medical device that received FDA 510(k) clearance on 2025-01-06. The listed applicant is Fesariustherapeutics, Inc.. The 510(k) number is K241904.

When did DermiSphere Dermal Template receive FDA 510(k) clearance?

DermiSphere Dermal Template received FDA 510(k) clearance on 2025-01-06, under 510(k) number K241904.

Who is the listed applicant for DermiSphere Dermal Template?

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

What is the FDA product code for DermiSphere Dermal Template?

The FDA product code for DermiSphere Dermal Template 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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