FDA 510(k)

Rezum System

Número K: K262460 · 2026-09-03

Data da decisão2026-09-03

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rezum System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2026-09-03 under 510(k) number K262460. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rezum System?

Rezum System is a medical device that received FDA 510(k) clearance on 2026-09-03. The listed applicant is Boston Scientific. The 510(k) number is K262460.

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

Rezum System received FDA 510(k) clearance on 2026-09-03, under 510(k) number K262460.

Who is the listed applicant for Rezum System?

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

What is the FDA product code for Rezum System?

The FDA product code for Rezum System is KNS.

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