Atlas FDA

GCA

26 FDA 510(k) clearances · Product code

126 daysmedian time to decision
232 days90th percentile
26clearances measured

FDA profile

Official device name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5010
Medical specialty
Gastroenterology, Urology
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 38 · 2019: 38 · 2020: 20 · 2022: 18 · 2025: 24 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Disposable Stone Retrieval Balloon Catheter (K253013)Zhejiang Soudon Medical Technology Co., Ltd.2026-05-08
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) (K232752)Jiangsu Vedkang Medical Science and Technology Co., Ltd.2024-02-26
SpyGlass Discover Balloon Dilation Catheter (K212582)Boston Scientific Corporation2022-05-06
Stone Retrieval Balloon Catheter (K210660)Anrei Medical (Hangzhou) Co., Ltd.2021-04-27
Stone Retrieval Balloon (K200173)Hangzhou AGS MedTech Co., Ltd.2020-05-01
Fusion Quattro Extraction Balloon (K200247)Wilson-Cook Medical, Inc.2020-02-27
Tri-Ex Extraction Balloon with Multiple Sizing (K193344)Wilson-Cook Medical, Inc.2019-12-13
Howell D.A.S.H Extraction Balloon with Multiple Sizing (K173659)Wilson-Cook Medical, Inc.2018-07-06
Advance Biliary Balloon Catheter (K173414)Cook Incorporated2018-06-22
Tri-Ex Extraction Balloon With Multiple Sizing (K170292)Wilson-Cook Medical, Inc.2017-09-20
FUSION QUATTRO EXTRACTION BALLOON XL (K063677)Wilson-Cook Medical, Inc.2007-01-05
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING (K040129)Wilson-Cook Medical, Inc.2004-02-27
TAUT BALLOON CATHETER, MODEL 50640 (K011018)Taut, Inc.2001-06-22
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR (K980917)Fortune Medical Instrument Corp.1998-05-27
WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR (K953951)Wilson-Cook Medical, Inc.1995-09-19
MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER (K931619)Boston Scientific Corp1993-08-20
BARD STONE REMOVAL BALLOON CATHETER (K920342)C.R. Bard, Inc.1992-08-26
CATHETER WITH INTRODUCER AND SYRINGES (K915129)Utah Pioneer Medical, Inc.1992-04-08
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (K915343)Uresil Corp.1992-03-31
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT (K914755)Davol, Inc.1992-03-30
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT (K915506)United States Endoscopy Group, Inc.1992-03-06
SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT (K913294)Surgitek Medical Engineering Corp.1991-10-04
LAPAROSCOPIC CHOLANGIOCATH (K911487)United States Endoscopy Group, Inc.1991-08-14
CATHLAB SILICONE BILIARY BALLOON CATHETER (K910917)Cathlab Corp.1991-08-02
INTIMAX(TM) IRRIGATION CATHETER (K911181)Applied Vascular Devices, Inc.1991-04-18
T-TUBE WHELAN-MOSS (K772292)Davol, Inc.1977-12-20

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Every clearance here is in the API, with alerts when new ones post.