FDA 510(k)

AGNES Ultra

Número K: K250217 · 2025-09-03

Data da decisão2025-09-03

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

AGNES Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Agnes Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K250217. 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 AGNES Ultra?

AGNES Ultra is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Agnes Medical Co., Ltd.. The 510(k) number is K250217.

When did AGNES Ultra receive FDA 510(k) clearance?

AGNES Ultra received FDA 510(k) clearance on 2025-09-03, under 510(k) number K250217.

Who is the listed applicant for AGNES Ultra?

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

What is the FDA product code for AGNES Ultra?

The FDA product code for AGNES Ultra is GEI.

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Fonte oficial

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