FDA.reportPublic FDA data

510(k) K253013

Device
Disposable Stone Retrieval Balloon Catheter
Applicant
Zhejiang Soudon Medical Technology Co., Ltd.
510(k) number
K253013
Product code
GCA
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-08
Date received
2025-09-19
Regulation
876.5010
Classification name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
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
Junshi Wang
Address
Rm. 302-1, Floor 3, Bldg. 4, #1 Nangonghe Rd., Donghu St., Linping District Hangzhou CN 311100 311100

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GCA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-26
K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation2022-05-06
K210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd.2021-04-27
K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.2020-05-01
K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.2020-02-27
K193344Tri-Ex Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc.2019-12-13
K173659Howell D.A.S.H Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc.2018-07-06
K173414Advance Biliary Balloon CatheterCook Incorporated2018-06-22
K170292Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc.2017-09-20
K063677FUSION QUATTRO EXTRACTION BALLOON XLWilson-Cook Medical, Inc.2007-01-05
K040129TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZINGWilson-Cook Medical, Inc.2004-02-27
K011018TAUT BALLOON CATHETER, MODEL 50640Taut, Inc.2001-06-22
K980917ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIRFortune Medical Instrument Corp.1998-05-27
K953951WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTORWilson-Cook Medical, Inc.1995-09-19
K931619MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETERBoston Scientific Corp1993-08-20