FDA 510(k)

Profisil Free

Número K: K262243 · 2026-09-03

Data da decisão2026-09-03

Código do produtoLBH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Profisil Free is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K262243. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Profisil Free?

Profisil Free is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K262243.

When did Profisil Free receive FDA 510(k) clearance?

Profisil Free received FDA 510(k) clearance on 2026-09-03, under 510(k) number K262243.

Who is the listed applicant for Profisil Free?

The FDA 510(k) record lists Kettenbach GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profisil Free?

The FDA product code for Profisil Free is LBH.

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Fonte oficial

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