Dislodger, Stone, Biliary
FDA product code LQR · Class II (moderate risk) · 21 CFR 876.5010 · Gastroenterology, Urology
38510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Cook, Inc. 6
- Boston Scientific Corporation 6
- Wilson-Cook Medical, Inc. 3
- Olympus Medical Systems Corp. 3
- Ideal Medical, Inc. 2
- Wiltek Medical, Inc. 2
- Medi-Globe Corp. 1
- Zhejiang Soudon Medical Technology Co., Ltd. 1
- Scivita Medical Technology Co., Ltd. 1
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. 1
- Hangzhou AGS MedTech Co., Ltd. 1
- Rsh, LLC 1
- Percutaneous Systems, Inc. 1
- Vascutech, Inc. 1
- KARL STORZ Endoscopy-America, Inc. 1
- Lsvp Intl., Inc. 1
- Mill-Rose Laboratory 1
- Cape Tech Medical Products 1
- Annex Medical, Inc. 1
- Medical Dynamics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253056 | Disposable Stone Extraction BasketLQR · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 04/03/2026SE |
| K243807 | Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432PLQR · Traditional | Olympus Medical Systems Corp. | 03/18/2025SE |
| K243471 | Extraction BasketLQR · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/16/2024SE |
| K240192 | Single-use Extraction BasketsLQR · Traditional | Scivita Medical Technology Co., Ltd. | 10/15/2024SE |
| K230598 | Stone Extraction BasketsLQR · Traditional | Jiangsu Vedkang Medical Science and Technology… | 09/12/2023SE |
| K203322 | SpyGlass Discover Retrieval BasketLQR · Traditional | Boston Scientific Corporation | 05/26/2021SE |
| K201509 | Disposable Stone Extraction basketLQR · Traditional | Hangzhou AGS MedTech Co., Ltd. | 12/16/2020SE |
| K191789 | Stonetome Stone Removal DeviceLQR · Special | Boston Scientific Corporation | 07/25/2019SESK |
| K182381 | Wilson-Cook Mini BasketLQR · Traditional | Wilson-Cook Medical, Inc. | 10/30/2018SE |
| K171969 | Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5…LQR · Traditional | Wilson-Cook Medical, Inc. | 03/28/2018SE |
| K171915 | Nathanson Transcystic Bile Duct Stone Exploration PackLQR · Traditional | Cook Incorporated | 03/01/2018SE |
| K173687 | Strange Bile Duct Stone Exploration SetLQR · Traditional | Cook Incorporated | 12/15/2017SESK |
| K170898 | Wittich Nitinol Stone BasketLQR · Traditional | Cook Incorporated | 12/12/2017SE |
| K170811 | Single Use Retrieval Nitinol Basket VLQR · Traditional | Olympus Medical Systems Corp. | 11/27/2017SE |
| K173009 | NCompass Nitinol Stone ExtractorsLQR · Traditional | Cook Incorporated | 11/07/2017SE |
| K131642 | RSH Biliary Stone Removal DeviceLQR · Traditional | Rsh, LLC | 08/07/2013SE |
| K091495 | Single Use 3-LUMEN Extraction Balloon V, Model V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B…LQR · Traditional | Olympus Medical Systems Corporation | 09/03/2009SE |
| K090485 | Coaxial Accordion Ercp Device, Models C0AC19001, COAC20005, COAC22003LQR · Traditional | Percutaneous Systems, Incorporated | 07/22/2009SE |
| K071066 | Spycatch Stone Retrieval BasketLQR · Special | Boston Scientific Corp | 06/29/2007SE |
| K992941 | Lemaitre Biliary CatheterLQR · Traditional | Vascutech, Inc. | 01/12/2000SE |
| K952149 | Karl Storz Take-Apart Rotating Grasping ForcepsLQR · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/15/1995SE |
| K946358 | Endoscopic Biliary CatheterLQR · Traditional | Boston Scientific Corp | 04/11/1995SE |
| K945295 | LSVP International Grasping ForcepsLQR · Traditional | Lsvp Intl., Inc. | 03/08/1995SE |
| K942005 | Gip/Med-Globe Stone Extractor BasketsLQR · Traditional | Medi-Globe Corp. | 11/22/1994SE |
| K931115 | Hatcher Stone-Embolis ExtractorLQR · Traditional | Ideal Medical, Inc. | 08/20/1993SE |
| K925879 | Microvasive Insurg Flat Wire BasketsLQR · Traditional | Boston Scientific Corp | 02/08/1993SE |
| K926040 | Heli-Tech Retrieval BasketLQR · Traditional | Cape Tech Medical Products | 12/23/1992SE |
| K925495 | Microvasive Insurg Helical & Mini-Helical BasketsLQR · Traditional | Boston Scientific Corp | 12/23/1992SE |
| K925559 | Biliary Stone DislodgerLQR · Traditional | Annex Medical, Inc. | 12/17/1992SE |
| K915538 | Over the Wire Stone BasketLQR · Traditional | Medical Dynamics, Inc. | 03/20/1992SE |
| K904472 | Glassman Stone Extraction SetLQR · Traditional | Wilson-Cook Medical, Inc. | 12/28/1990SE |
| K902945 | Cope Nitinol Stone BasketLQR · Traditional | Cook, Inc. | 09/12/1990SE |
| K902944 | Wittich Nitinol Stone BasketLQR · Traditional | Cook, Inc. | 09/12/1990SE |
| K894866 | Wiltek Stone ExtractorLQR · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K894865 | Wiltek Balloon Stone ExtractorLQR · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K891588 | Tri-Lumen Intra Vascular Balloon Catheter (Gu Use)LQR · Traditional | Ideal Medical, Inc. | 09/28/1989SE |
| K862949 | Hatcher Stone Extractor - Disposable CatheterLQR · Traditional | Oscor Medical Corp. | 10/31/1986SE |
| K850489 | Endosopic Stene Manipulating BalloonLQR · Traditional | Mill-Rose Laboratory | 04/22/1985SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1787-2026 Class II | COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Cook Incorporated | 03/05/2026Open, Classified |
| Z-1784-2026 Class II | COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Cook Incorporated | 03/05/2026Open, Classified |
| Z-1012-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm…The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the… | Boston Scientific Corp | 01/08/2009Terminated |
| Z-1011-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr…The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the… | Boston Scientific Corp | 01/08/2009Terminated |
| Z-1010-2009 | Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr…The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the… | Boston Scientific Corp | 01/08/2009Terminated |