Product Code: LQR FDA class 2 21 CFR 876.5010

Dislodger, Stone, Biliary

Gastroenterology, Urology

The Biliary Stone Dislodger is an endoscopic device used to dislodge or reposition bile duct stones to facilitate their extraction or passage, typically used in conjunction with other biliary stone removal instruments during endoscopic retrograde cholangiopancreatography (ERCP). It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LQR, regulated under 21 CFR 876.5010, within the Gastroenterology and Urology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LQR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LQR
Device Class: FDA class 2
Regulation Number: 876.5010
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253056	Disposable Stone Extraction Basket	Apr 03, 2026	Substantially Equivalent	Zhejiang Soudon Medical Technology Co., Ltd.
K243807	Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P	Mar 18, 2025	Substantially Equivalent	Olympus Medical Systems Corp.
K243471	Extraction Basket	Dec 16, 2024	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K240192	Single-use Extraction Baskets	Oct 15, 2024	Substantially Equivalent	Scivita Medical Technology Co., Ltd.
K230598	Stone Extraction Baskets	Sep 12, 2023	Substantially Equivalent	Jiangsu Vedkang Medical Science and Technology Co., Ltd.
K203322	SpyGlass Discover Retrieval Basket	May 26, 2021	Substantially Equivalent	Boston Scientific Corporation
K201509	Disposable Stone Extraction basket	Dec 16, 2020	Substantially Equivalent	Hangzhou AGS MedTech Co., Ltd.
K191789	Stonetome Stone Removal Device	Jul 25, 2019	Unknown	Boston Scientific Corporation
K182381	Wilson-Cook Mini Basket	Oct 30, 2018	Substantially Equivalent	Wilson-Cook Medical, Inc.
K171969	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	Mar 28, 2018	Substantially Equivalent	Wilson-Cook Medical, Inc.
K171915	Nathanson Transcystic Bile Duct Stone Exploration Pack	Mar 01, 2018	Substantially Equivalent	Cook Incorporated
K173687	Strange Bile Duct Stone Exploration Set	Dec 15, 2017	Unknown	Cook Incorporated
K170898	Wittich Nitinol Stone Basket	Dec 12, 2017	Substantially Equivalent	Cook Incorporated
K170811	Single Use Retrieval Nitinol Basket V	Nov 27, 2017	Substantially Equivalent	Olympus Medical Systems Corp.
K173009	NCompass Nitinol Stone Extractors	Nov 07, 2017	Substantially Equivalent	Cook Incorporated
K131642	RSH BILIARY STONE REMOVAL DEVICE	Aug 07, 2013	Substantially Equivalent	Rsh, LLC
K091495	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	Sep 03, 2009	Substantially Equivalent	Olympus Medical Systems Corporation
K090485	COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003	Jul 22, 2009	Substantially Equivalent	Percutaneous Systems, Incorporated
K071066	SPYCATCH STONE RETRIEVAL BASKET	Jun 29, 2007	Substantially Equivalent	Boston Scientific Corp
K992941	LEMAITRE BILIARY CATHETER	Jan 12, 2000	Substantially Equivalent	Vascutech, Inc.
K952149	KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS	Jun 15, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K946358	ENDOSCOPIC BILIARY CATHETER	Apr 11, 1995	Substantially Equivalent	Boston Scientific Corp
K945295	LSVP INTERNATIONAL GRASPING FORCEPS	Mar 08, 1995	Substantially Equivalent	Lsvp Intl., Inc.
K942005	GIP/MED-GLOBE STONE EXTRACTOR BASKETS	Nov 22, 1994	Substantially Equivalent	Medi-Globe Corp.
K931115	HATCHER STONE-EMBOLIS EXTRACTOR	Aug 20, 1993	Substantially Equivalent	Ideal Medical, Inc.
K925879	MICROVASIVE INSURG FLAT WIRE BASKETS	Feb 08, 1993	Substantially Equivalent	Boston Scientific Corp
K926040	HELI-TECH RETRIEVAL BASKET	Dec 23, 1992	Substantially Equivalent	Cape Tech Medical Products
K925495	MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS	Dec 23, 1992	Substantially Equivalent	Boston Scientific Corp
K925559	BILIARY STONE DISLODGER	Dec 17, 1992	Substantially Equivalent	Annex Medical, Inc.
K915538	OVER THE WIRE STONE BASKET	Mar 20, 1992	Substantially Equivalent	Medical Dynamics, Inc.
K904472	GLASSMAN STONE EXTRACTION SET	Dec 28, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K902945	COPE NITINOL STONE BASKET	Sep 12, 1990	Substantially Equivalent	Cook, Inc.
K902944	WITTICH NITINOL STONE BASKET	Sep 12, 1990	Substantially Equivalent	Cook, Inc.
K894866	WILTEK STONE EXTRACTOR	Dec 21, 1989	Substantially Equivalent	Wiltek Medical, Inc.
K894865	WILTEK BALLOON STONE EXTRACTOR	Dec 21, 1989	Substantially Equivalent	Wiltek Medical, Inc.
K891588	TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)	Sep 28, 1989	Substantially Equivalent	Ideal Medical, Inc.
K862949	HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER	Oct 31, 1986	Substantially Equivalent	Oscor Medical Corp.
K850489	ENDOSOPIC STENE MANIPULATING BALLOON	Apr 22, 1985	Substantially Equivalent	Mill-Rose Laboratory