FDA 510(k)

InbellaMAX System

Número K: K252215 · 2025-07-25

Data da decisão2025-07-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

InbellaMAX System is the device name listed in this FDA 510(k) record. The listed applicant is Inbella Medical , Ltd.. It received FDA 510(k) clearance on 2025-07-25 under 510(k) number K252215. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InbellaMAX System?

InbellaMAX System is a medical device that received FDA 510(k) clearance on 2025-07-25. The listed applicant is Inbella Medical , Ltd.. The 510(k) number is K252215.

When did InbellaMAX System receive FDA 510(k) clearance?

InbellaMAX System received FDA 510(k) clearance on 2025-07-25, under 510(k) number K252215.

Who is the listed applicant for InbellaMAX System?

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

What is the FDA product code for InbellaMAX System?

The FDA product code for InbellaMAX System is GEI.

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