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FDA 510(k)

Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)

Número K: K240074 · 2024-10-04

RequerenteShenzhen Besdata Technology Co., Ltd.
Data da decisão2024-10-04
Código do produtoFGB
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Besdata Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K240074. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)?

Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Shenzhen Besdata Technology Co., Ltd.. The 510(k) number is K240074.

When did Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) receive FDA 510(k) clearance?

Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) received FDA 510(k) clearance on 2024-10-04, under 510(k) number K240074.

Who is the listed applicant for Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)?

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

What is the FDA product code for Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2)?

The FDA product code for Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) is FGB.

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