Lithotriptor, Biliary Mechanical
FDA product code LQC · Class II (moderate risk) · 21 CFR 876.4500 · Gastroenterology, Urology
11510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040447 | Trapezoid RX Lithotripter Compatible Basket, Models 1086, 1087, 1088LQC · Special | Boston Scientific Corp | 03/12/2004SE |
| K011178 | Wilson-Cook Thru-The-Scope Mechanical LithotriptorLQC · Special | Wilson-Cook Medical, Inc. | 05/04/2001SE |
| K964937 | A Lithotripter-Compatible BasketLQC · Traditional | Boston Scientific Corp | 01/24/1997SE |
| K942544 | Gip/Medi-Globe Mechanical Lithotriptor and BasketsLQC · Traditional | Medi-Globe Corp. | 11/22/1994SE |
| K943191 | Microvasive(R) Monolith(Tm) Mechanical LithotriptorLQC · Traditional | Boston Scientific Corp | 08/29/1994SE |
| K905552 | LaparolithLQC · Traditional | Baxter Healthcare Corp | 12/17/1991SE |
| K911364 | Spoon Forceps, 11MMLQC · Traditional | Northgate Technologies, Inc. | 10/23/1991SE |
| K911477 | Laparoscopic Basket Flexible and RigidLQC · Traditional | United States Endoscopy Group, Inc. | 08/14/1991SE |
| K903529 | BML SeriesLQC · Traditional | Olympus Corp. | 01/23/1991SE |
| K902170 | Soehendra Lithotripsy SetLQC · Traditional | Wilson-Cook Medical, Inc. | 07/25/1990SE |
| K860863 | Endo-Tripton, Mechanical Gallstone CrusherLQC · Traditional | George Percy Mcgown | 05/15/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0962-2025 Class II | LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single…Potential for distal tip tearing of the Mechanical Lithotriptor V. | Olympus Corporation of the Americas | 12/16/2024Open, Classified |
| Z-1068-2021 Class II | MAJ-247 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-247 - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1067-2021 Class II | MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage:…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-0108-2008 | Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc.Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath | Olympus America Inc. | 09/20/2007Terminated |
| Z-0107-2008 | Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America…Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath | Olympus America Inc. | 09/20/2007Terminated |
| Z-0106-2008 | Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America…Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath | Olympus America Inc. | 09/20/2007Terminated |
| Z-0105-2008 | Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America…Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath | Olympus America Inc. | 09/20/2007Terminated |