FDA 510(k)

Disposable Ureteral Guide Sheath

Número K: K241181 · 2024-08-02

RequerenteDongguan Zsr Biomedical Technology Company Limited

Data da decisão2024-08-02

Código do produtoFED

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Ureteral Guide Sheath 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 2024-08-02 under 510(k) number K241181. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Ureteral Guide Sheath?

Disposable Ureteral Guide Sheath is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Dongguan Zsr Biomedical Technology Company Limited. The 510(k) number is K241181.

When did Disposable Ureteral Guide Sheath receive FDA 510(k) clearance?

Disposable Ureteral Guide Sheath received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241181.

Who is the listed applicant for Disposable Ureteral Guide Sheath?

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 Disposable Ureteral Guide Sheath?

The FDA product code for Disposable Ureteral Guide Sheath is FED.

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Outros registros que listam Dongguan Zsr Biomedical Technology Company Limited como candidato(a)

K243155Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)

Dispositivos Relacionados (Código: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Fonte oficial

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