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GCA — Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Class II

FDA Device Classification

FDA product code GCA covers "Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection", a Class II medical device regulated under 21 CFR 876.5010. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GCA
Device Class
Class II
Regulation Number
876.5010
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253013zhejiang soudon medical technology coDisposable Stone Retrieval Balloon CatheterMay 8, 2026
K232752jiangsu vedkang medical science and technology coStone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23February 26, 2024
K212582boston scientific corporationSpyGlass Discover Balloon Dilation CatheterMay 6, 2022
K210660anrei medical (hangzhou) coStone Retrieval Balloon CatheterApril 27, 2021
K200173hangzhou ags medtech coStone Retrieval BalloonMay 1, 2020
K200247wilson-cook medicalFusion Quattro Extraction BalloonFebruary 27, 2020
K193344wilson-cook medicalTri-Ex Extraction Balloon with Multiple SizingDecember 13, 2019
K173659wilson-cook medicalHowell D.A.S.H Extraction Balloon with Multiple SizingJuly 6, 2018
K173414cook incorporatedAdvance Biliary Balloon CatheterJune 22, 2018
K170292wilson-cook medicalTri-Ex Extraction Balloon With Multiple SizingSeptember 20, 2017
K063677wilson-cook medicalFUSION QUATTRO EXTRACTION BALLOON XLJanuary 5, 2007
K040129wilson-cook medicalTRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZINGFebruary 27, 2004
K011018tautTAUT BALLOON CATHETER, MODEL 50640June 22, 2001
K980917fortune medical instrumentALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESMay 27, 1998
K953951wilson-cook medicalWILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTORSeptember 19, 1995
K931619boston scientificMICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETERAugust 20, 1993
K920342c.r. bardBARD STONE REMOVAL BALLOON CATHETERAugust 26, 1992
K915129utah pioneer medicalCATHETER WITH INTRODUCER AND SYRINGESApril 8, 1992
K915343uresilURESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERMarch 31, 1992
K914755davolDAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KITMarch 30, 1992

FDA data resources