FDA 510(k)

Jada System (Jada-2002)

Número K: K253642 · 2026-05-15

Data da decisão2026-05-15

Código do produtoOQY

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Jada System (Jada-2002) is the device name listed in this FDA 510(k) record. The listed applicant is Organon, LLC. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K253642. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Jada System (Jada-2002)?

Jada System (Jada-2002) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Organon, LLC. The 510(k) number is K253642.

When did Jada System (Jada-2002) receive FDA 510(k) clearance?

Jada System (Jada-2002) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K253642.

Who is the listed applicant for Jada System (Jada-2002)?

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

What is the FDA product code for Jada System (Jada-2002)?

The FDA product code for Jada System (Jada-2002) is OQY.

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Fonte oficial

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