FDA.reportPublic FDA data

510(k) K242192

Device
Disposable Sphincterotome
Applicant
Beijing Zksk Technology Co., Ltd.
510(k) number
K242192
Product code
KNS
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-06
Date received
2024-07-26
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

Applicant Contact#

Contact
Li Ma
Address
Bldg. 9, 6 & #6 Yuan Hengye N. 7th St., Yongle Economic Development Zone, Tongzhou District Beijing CN 101105 101105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260962SphincterotomeTaewoong Medical Co., Ltd.2026-05-21
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
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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
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
K232825Disposable SphincterotomeJiangsu Vedkang Medical Science and Technology Co., Ltd.2024-03-29
K232633Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific2023-11-28