FDA 510(k)

Single Use Suction-Evacuation Ureteral Access Sheath

Numéro K : K250128 · 2025-09-19

DemandeurAnhui Happiness Workshop Medical Instruments Co., Ltd.

Date de décision2025-09-19

Code produitFED

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Single Use Suction-Evacuation Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Happiness Workshop Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K250128. 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 Single Use Suction-Evacuation Ureteral Access Sheath?

Single Use Suction-Evacuation Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Anhui Happiness Workshop Medical Instruments Co., Ltd.. The 510(k) number is K250128.

When did Single Use Suction-Evacuation Ureteral Access Sheath receive FDA 510(k) clearance?

Single Use Suction-Evacuation Ureteral Access Sheath received FDA 510(k) clearance on 2025-09-19, under 510(k) number K250128.

Who is the listed applicant for Single Use Suction-Evacuation Ureteral Access Sheath?

The FDA 510(k) record lists Anhui Happiness Workshop Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Suction-Evacuation Ureteral Access Sheath?

The FDA product code for Single Use Suction-Evacuation 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.