FDA 510(k)

Mendaera Guidance System

Número K: K250524 · 2025-07-02

Data da decisão2025-07-02

Código do produtoITX

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mendaera Guidance System is the device name listed in this FDA 510(k) record. The listed applicant is Mendaera, Inc.. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250524. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mendaera Guidance System?

Mendaera Guidance System is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Mendaera, Inc.. The 510(k) number is K250524.

When did Mendaera Guidance System receive FDA 510(k) clearance?

Mendaera Guidance System received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250524.

Who is the listed applicant for Mendaera Guidance System?

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

What is the FDA product code for Mendaera Guidance System?

The FDA product code for Mendaera Guidance System is ITX.

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Fonte oficial

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