LQR · Class II · 21 CFR 876.5010

FDA Product Code LQR: Dislodger, Stone, Biliary

FDA product code LQR covers biliary stone dislodgers used endoscopically or percutaneously to break up and remove calculi from the bile ducts.

These basket, balloon, or mechanical lithotripsy devices are used to capture, fragment, and extract stones from the common bile duct during ERCP procedures, avoiding the need for surgical common bile duct exploration.

LQR devices are Class II medical devices, regulated under 21 CFR 876.5010 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Cook Incorporated, Boston Scientific Corp and Wilson-Cook Medical, Inc..

38
Total
38
Cleared
123d
Avg days
1985
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 109d avg (recent)

FDA 510(k) Cleared Dislodger, Stone, Biliary Devices (Product Code LQR)

38 devices
1–24 of 38
Cleared Apr 03, 2026
Disposable Stone Extraction Basket
K253056
Zhejiang Soudon Medical Technology Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Mar 18, 2025
Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P
K243807
Olympus Medical Systems Corp.
Gastroenterology & Urology · 97d
Cleared Dec 16, 2024
Extraction Basket
K243471
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 38d
Cleared Oct 15, 2024
Single-use Extraction Baskets
K240192
Scivita Medical Technology Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Sep 12, 2023
Stone Extraction Baskets
K230598
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Gastroenterology & Urology · 193d
Cleared May 26, 2021
SpyGlass Discover Retrieval Basket
K203322
Boston Scientific Corporation
Gastroenterology & Urology · 195d
Cleared Dec 16, 2020
Disposable Stone Extraction basket
K201509
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 194d
Cleared Jul 25, 2019
Stonetome Stone Removal Device
K191789
Boston Scientific Corporation
Gastroenterology & Urology · 22d
Cleared Oct 30, 2018
Wilson-Cook Mini Basket
K182381
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Mar 28, 2018
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
K171969
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Mar 01, 2018
Nathanson Transcystic Bile Duct Stone Exploration Pack
K171915
Cook Incorporated
Gastroenterology & Urology · 248d
Cleared Dec 15, 2017
Strange Bile Duct Stone Exploration Set
K173687
Cook Incorporated
Gastroenterology & Urology · 14d
Cleared Dec 12, 2017
Wittich Nitinol Stone Basket
K170898
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Nov 27, 2017
Single Use Retrieval Nitinol Basket V
K170811
Olympus Medical Systems Corp.
Gastroenterology & Urology · 255d
Cleared Nov 07, 2017
NCompass Nitinol Stone Extractors
K173009
Cook Incorporated
Gastroenterology & Urology · 41d
Cleared Aug 07, 2013
RSH BILIARY STONE REMOVAL DEVICE
K131642
Rsh, LLC
Gastroenterology & Urology · 64d
Cleared Sep 03, 2009
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
K091495
Olympus Medical Systems Corporation
Gastroenterology & Urology · 106d
Cleared Jul 22, 2009
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
K090485
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 147d
Cleared Jun 29, 2007
SPYCATCH STONE RETRIEVAL BASKET
K071066
Boston Scientific Corp
Gastroenterology & Urology · 74d
Cleared Jan 12, 2000
LEMAITRE BILIARY CATHETER
K992941
Vascutech, Inc.
Gastroenterology & Urology · 134d
Cleared Jun 15, 1995
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 38d
Cleared Apr 11, 1995
ENDOSCOPIC BILIARY CATHETER
K946358
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared Mar 08, 1995
LSVP INTERNATIONAL GRASPING FORCEPS
K945295
Lsvp Intl., Inc.
Gastroenterology & Urology · 128d
Cleared Nov 22, 1994
GIP/MED-GLOBE STONE EXTRACTOR BASKETS
K942005
Medi-Globe Corp.
Gastroenterology & Urology · 211d

About Product Code LQR - Regulatory Context

510(k) Submission Activity

38 total 510(k) submissions under product code LQR since 1985, with 38 receiving FDA clearance (average review time: 123 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LQR Product Code

FDA review times for LQR submissions have been consistent, averaging 109 days recently vs 124 days historically.

LQR devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →