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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 a medical device manufactured by Fesariustherapeutics, Inc.. It received FDA 510(k) clearance on 2025-01-06 under approval 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. It is manufactured by Fesariustherapeutics, Inc.. The 510(k) number is K241904.

When was DermiSphere Dermal Template approved by the FDA?

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

What company makes DermiSphere Dermal Template?

DermiSphere Dermal Template is manufactured by Fesariustherapeutics, Inc..

What is the FDA product code for DermiSphere Dermal Template?

The FDA product code for DermiSphere Dermal Template is KGN.

Related Devices (Code: KGN)

K160136Flowable Wound MatrixCook Biotech Incorporated K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. K153754MicroMatrixAcell, Inc. K153690PriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. K172010gel-e BandageGel-E, Inc. (Formerly Remedium Technologies, Inc.) K171842Geistlich Wound MatrixGeistlich Pharma 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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