FDA 510(k)

RZ Resectoscope System

Número K: K243382 · 2025-06-03

Data da decisão2025-06-03

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

RZ Resectoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Rz Medizintechnik GmbH. It received FDA 510(k) clearance on 2025-06-03 under 510(k) number K243382. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RZ Resectoscope System?

RZ Resectoscope System is a medical device that received FDA 510(k) clearance on 2025-06-03. The listed applicant is Rz Medizintechnik GmbH. The 510(k) number is K243382.

When did RZ Resectoscope System receive FDA 510(k) clearance?

RZ Resectoscope System received FDA 510(k) clearance on 2025-06-03, under 510(k) number K243382.

Who is the listed applicant for RZ Resectoscope System?

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

What is the FDA product code for RZ Resectoscope System?

The FDA product code for RZ Resectoscope System is HIH.

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Fonte oficial

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