FDA 510(k)

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)

Número K: K243155 · 2025-02-11

RequerenteDongguan Zsr Biomedical Technology Company Limited

Data da decisão2025-02-11

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K243155. 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 Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)?

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K243155.

When did Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) receive FDA 510(k) clearance?

Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243155.

Who is the listed applicant for Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)?

The FDA 510(k) record lists Dongguan Zsr Biomedical Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)?

The FDA product code for Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) is FGB.

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