FDA 510(k)

Excelsior System

Número K: K253291 · 2026-01-20

Data da decisão2026-01-20

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Excelsior System is the device name listed in this FDA 510(k) record. The listed applicant is Blue Ocean Global. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253291. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Excelsior System?

Excelsior System is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Blue Ocean Global. The 510(k) number is K253291.

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

Excelsior System received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253291.

Who is the listed applicant for Excelsior System?

The FDA 510(k) record lists Blue Ocean Global as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Excelsior System?

The FDA product code for Excelsior System is KTT.

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Fonte oficial

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