FDA 510(k)

DermiSphere Dermal Template

Número K: K241904 · 2025-01-06

Data da decisão2025-01-06

Código do produtoKGN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: KGN)

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Fonte oficial

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