FDA 510(k)

Rezum System

N.º K: K262460 · 2026-09-03

Fecha de decisión2026-09-03

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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