FDA 510(k)

Ossiclear (Ossiclear System)

Número K: K254296 · 2026-07-22

Data da decisão2026-07-22

Código do produtoLXB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ossiclear (Ossiclear System) is the device name listed in this FDA 510(k) record. The listed applicant is Sounduct. It received FDA 510(k) clearance on 2026-07-22 under 510(k) number K254296. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ossiclear (Ossiclear System)?

Ossiclear (Ossiclear System) is a medical device that received FDA 510(k) clearance on 2026-07-22. The listed applicant is Sounduct. The 510(k) number is K254296.

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

Ossiclear (Ossiclear System) received FDA 510(k) clearance on 2026-07-22, under 510(k) number K254296.

Who is the listed applicant for Ossiclear (Ossiclear System)?

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

What is the FDA product code for Ossiclear (Ossiclear System)?

The FDA product code for Ossiclear (Ossiclear System) is LXB.

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