FDA 510(k)

Sistema de CrioCatheter Flexível Celsio

Número K: K240776 · 2024-09-24

Data da decisão2024-09-24

Código do produtoGEH

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Celsio Flexible Cryocatheter System is the device name listed in this FDA 510(k) record. The listed applicant is Endocision Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-24 under 510(k) number K240776. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Celsio Flexible Cryocatheter System?

Celsio Flexible Cryocatheter System is a medical device that received FDA 510(k) clearance on 2024-09-24. The listed applicant is Endocision Technologies, Inc.. The 510(k) number is K240776.

When did Celsio Flexible Cryocatheter System receive FDA 510(k) clearance?

Celsio Flexible Cryocatheter System received FDA 510(k) clearance on 2024-09-24, under 510(k) number K240776.

Who is the listed applicant for Celsio Flexible Cryocatheter System?

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

What is the FDA product code for Celsio Flexible Cryocatheter System?

The FDA product code for Celsio Flexible Cryocatheter System is GEH.

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