Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

FDA product code GCA · 26 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5010
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-12-20 – 2026-05-08

GCA 2026-05-08

Disposable Stone Retrieval Balloon Catheter

Applicant Zhejiang Soudon Medical Technology Co., Ltd.

K number K253013

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GCA 2024-02-26

Stone 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)

Applicant Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K number K232752

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GCA 2022-05-06

SpyGlass Discover Balloon Dilation Catheter

Applicant Boston Scientific Corporation

K number K212582

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GCA 2021-04-27

Stone Retrieval Balloon Catheter

Applicant Anrei Medical (Hangzhou) Co., Ltd.

K number K210660

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GCA 2020-05-01

Stone Retrieval Balloon

Applicant Hangzhou AGS MedTech Co., Ltd.

K number K200173

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GCA 2020-02-27

Fusion Quattro Extraction Balloon

Applicant Wilson-Cook Medical, Inc.

K number K200247

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GCA 2019-12-13

Tri-Ex Extraction Balloon with Multiple Sizing

Applicant Wilson-Cook Medical, Inc.

K number K193344

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GCA 2018-07-06

Howell D.A.S.H Extraction Balloon with Multiple Sizing

Applicant Wilson-Cook Medical, Inc.

K number K173659

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GCA 2018-06-22

Advance Biliary Balloon Catheter

Applicant Cook Incorporated

K number K173414

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GCA 2017-09-20

Tri-Ex Extraction Balloon With Multiple Sizing

Applicant Wilson-Cook Medical, Inc.

K number K170292

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GCA 2007-01-05

FUSION QUATTRO EXTRACTION BALLOON XL

Applicant Wilson-Cook Medical, Inc.

K number K063677

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GCA 2004-02-27

TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING

Applicant Wilson-Cook Medical, Inc.

K number K040129

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GCA 2001-06-22

TAUT BALLOON CATHETER, MODEL 50640

Applicant Taut, Inc.

K number K011018

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GCA 1998-05-27

ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR

Applicant Fortune Medical Instrument Corp.

K number K980917

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GCA 1995-09-19

WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR

Applicant Wilson-Cook Medical, Inc.

K number K953951

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GCA 1993-08-20

MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER

Applicant Boston Scientific Corp

K number K931619

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GCA 1992-08-26

BARD STONE REMOVAL BALLOON CATHETER

Applicant C.R. Bard, Inc.

K number K920342

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GCA 1992-04-08

CATHETER WITH INTRODUCER AND SYRINGES

Applicant Utah Pioneer Medical, Inc.

K number K915129

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GCA 1992-03-31

URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER

Applicant Uresil Corp.

K number K915343

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GCA 1992-03-30

DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT

Applicant Davol, Inc.

K number K914755

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GCA 1992-03-06

LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT

Applicant United States Endoscopy Group, Inc.

K number K915506

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GCA 1991-10-04

SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT

Applicant Surgitek Medical Engineering Corp.

K number K913294

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GCA 1991-08-14

LAPAROSCOPIC CHOLANGIOCATH

Applicant United States Endoscopy Group, Inc.

K number K911487

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GCA 1991-08-02

CATHLAB SILICONE BILIARY BALLOON CATHETER

Applicant Cathlab Corp.

K number K910917

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GCA 1991-04-18

INTIMAX(TM) IRRIGATION CATHETER

Applicant Applied Vascular Devices, Inc.

K number K911181

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GCA 1977-12-20

T-TUBE WHELAN-MOSS

Applicant Davol, Inc.

K number K772292

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