FDA 510(k)

KARL STORZ OR1™ SCB CONTROL (WU300)

Número K: K232406 · 2023-10-03

Data da decisão2023-10-03

Código do produtoODA

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

KARL STORZ OR1™ SCB CONTROL (WU300) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2023-10-03 under 510(k) number K232406. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the KARL STORZ OR1™ SCB CONTROL (WU300)?

KARL STORZ OR1™ SCB CONTROL (WU300) is a medical device that received FDA 510(k) clearance on 2023-10-03. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K232406.

When did KARL STORZ OR1™ SCB CONTROL (WU300) receive FDA 510(k) clearance?

KARL STORZ OR1™ SCB CONTROL (WU300) received FDA 510(k) clearance on 2023-10-03, under 510(k) number K232406.

Who is the listed applicant for KARL STORZ OR1™ SCB CONTROL (WU300)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300)?

The FDA product code for KARL STORZ OR1™ SCB CONTROL (WU300) is ODA.

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Fonte oficial

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