FDA.reportPublic FDA data

510(k) K210660

Device
Stone Retrieval Balloon Catheter
Applicant
Anrei Medical (Hangzhou) Co., Ltd.
510(k) number
K210660
Product code
GCA
Decision
Substantially Equivalent (SESE)
Decision date
2021-04-27
Date received
2021-03-04
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
No

Applicant Contact#

Contact
Huibing Yang
Address
#3 Ave.8, Heda Hangzhou CN 310018 310018

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
K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd.2026-05-08
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
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