FDA 510(k)

Ureteral Access Sheath

Numéro K : K250132 · 2025-09-05

DemandeurZhejiang YiGao Medical Technology Co., Ltd.

Date de décision2025-09-05

Code produitFED

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang YiGao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K250132. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Ureteral Access Sheath?

Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Zhejiang YiGao Medical Technology Co., Ltd.. The 510(k) number is K250132.

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

Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250132.

Who is the listed applicant for Ureteral Access Sheath?

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

What is the FDA product code for Ureteral Access Sheath?

The FDA product code for Ureteral Access Sheath is FED.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : 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.

Source officielle

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