FDA 510(k)

Orca Air/Water and Suction Valves

Número K: K252910 · 2025-10-09

Data da decisão2025-10-09

Código do produtoODC

Comité consultivoGU

DecisãoUnknown

Resumo do dispositivo

Orca Air/Water and Suction Valves is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K252910. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Perguntas frequentes

What is the Orca Air/Water and Suction Valves?

Orca Air/Water and Suction Valves is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Boston Scientific. The 510(k) number is K252910.

When did Orca Air/Water and Suction Valves receive FDA 510(k) clearance?

Orca Air/Water and Suction Valves received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252910.

Who is the listed applicant for Orca Air/Water and Suction Valves?

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 Orca Air/Water and Suction Valves?

The FDA product code for Orca Air/Water and Suction Valves is ODC.

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Fonte oficial

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