FDA 510(k)

METICULY Patient-specific CMF solution

Número K: K253206 · 2026-07-25

Data da decisão2026-07-25

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

METICULY Patient-specific CMF solution is the device name listed in this FDA 510(k) record. The listed applicant is Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2026-07-25 under 510(k) number K253206. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the METICULY Patient-specific CMF solution?

METICULY Patient-specific CMF solution is a medical device that received FDA 510(k) clearance on 2026-07-25. The listed applicant is Meticuly Co., Ltd.. The 510(k) number is K253206.

When did METICULY Patient-specific CMF solution receive FDA 510(k) clearance?

METICULY Patient-specific CMF solution received FDA 510(k) clearance on 2026-07-25, under 510(k) number K253206.

Who is the listed applicant for METICULY Patient-specific CMF solution?

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

Qual é o código de produto da FDA para a solução CMF específica do paciente METICULY?

The FDA product code for METICULY Patient-specific CMF solution is JEY.

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Fonte oficial

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