FDA.report

510(k) K232825

Device
Disposable Sphincterotome
Applicant
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
510(k) number
K232825
Product code
KNS
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-29
Date received
2023-09-13
Regulation
876.4300
Classification name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Yulu Shi
Address
#52, Guoxiang Rd., Wujin Economic Development Zone Changzhou CN 213149 213149

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code KNS

510(k)DeviceApplicantDecision date
K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.2025-11-26
K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation2025-11-25
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.2025-10-17
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 Corporation2025-10-10
K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical2025-09-29
K251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.2025-08-08
K250584Rezum SystemBoston Scientific Corporation2025-06-11
K242774SpydrBlade Flex Instrument (PRD-RG1-001)Creo Medical, Ltd.2025-06-06
K241855SB Knife Jr2 (MD-47702 and MD-47702L)Sb-Kawasumi Laboratories, Inc.2025-03-26
K242192Disposable SphincterotomeBeijing Zksk Technology Co., Ltd.2025-02-06
K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc.2025-01-17
K241271Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.2024-12-12
K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)Creo Medical, Ltd.2024-08-15
K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific2023-11-28
K232476Disposable SphincterotomeZhejiang Soudon Medical Technology Co., Ltd.2023-11-07