FDA 510(k)

Extracorporeal Shock Wave Lithotripter (U200)

Número K: K242922 · 2025-06-18

RequerenteShenzhen Wikkon Precision Technologies Co., Ltd.

Data da decisão2025-06-18

Código do produtoLNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Extracorporeal Shock Wave Lithotripter (U200) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242922. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Extracorporeal Shock Wave Lithotripter (U200)?

Extracorporeal Shock Wave Lithotripter (U200) is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. The 510(k) number is K242922.

When did Extracorporeal Shock Wave Lithotripter (U200) receive FDA 510(k) clearance?

Extracorporeal Shock Wave Lithotripter (U200) received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242922.

Who is the listed applicant for Extracorporeal Shock Wave Lithotripter (U200)?

The FDA 510(k) record lists Shenzhen Wikkon Precision Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extracorporeal Shock Wave Lithotripter (U200)?

The FDA product code for Extracorporeal Shock Wave Lithotripter (U200) is LNS.

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Dispositivos Relacionados (Código: LNS)

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Fonte oficial

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