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510(k) K192342

Device
Electrosurgical System (Electrosurgical Generator With Bipolar Polypectomy Snare Combination And Single Use Electrosurgical Knife Combination Accessories)
Applicant
Hangzhou AGS MedTech Co., Ltd.
510(k) number
K192342
Product code
KNS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-05-21
Date received
2019-08-28
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
No

Applicant Contact#

Contact
Chunqi Han
Address
Bldg. 5,Bldg. 6, #597 Kangxin Rd. Yuhang District Hangzhou CN 311106 311106

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
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
K232825Disposable SphincterotomeJiangsu Vedkang Medical Science and Technology Co., Ltd.2024-03-29

Legacy Summary#

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FDA Review#

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