FDA 510(k)

Disposable Sphincterotome

Número K: K232825 · 2024-03-29

RequerenteJiangsu Vedkang Medical Science and Technology Co., Ltd.

Data da decisão2024-03-29

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Vedkang Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-29 under 510(k) number K232825. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Sphincterotome?

Disposable Sphincterotome is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K232825.

When did Disposable Sphincterotome receive FDA 510(k) clearance?

Disposable Sphincterotome received FDA 510(k) clearance on 2024-03-29, under 510(k) number K232825.

Who is the listed applicant for Disposable Sphincterotome?

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

What is the FDA product code for Disposable Sphincterotome?

The FDA product code for Disposable Sphincterotome is KNS.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Jiangsu Vedkang Medical Science and Technology Co., Ltd. como candidato(a)

K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)K230598Stone Extraction Baskets K222146Disposable Endoscopic Hemoclip K220089Disposable Polyp Snare K213914Injection Needle

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.