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Lithotriptor, Biliary Mechanical
FDA product code LQC · Class 2 · Gastroenterology, Urology
38
Registered devices
2,875
Adverse events
7
Recalls
11
510(k) clearances
Devices with this code
Tube Sheath — OLYMPUS MEDICAL SYSTEMS CORP.Single Use Mechanical Lithotriptor V — OLYMPUS MEDICAL SYSTEMS CORP.Single Use Mechanical Lithotriptor V — OLYMPUS MEDICAL SYSTEMS CORP.Trapezoid RX — BOSTON SCIENTIFIC CORPORATIONDISPOSABLE MECHANICAL LITHOTRIPTOR — OLYMPUS MEDICAL SYSTEMS CORP.BML HANDLE — OLYMPUS MEDICAL SYSTEMS CORP.Basket Wire — OLYMPUS MEDICAL SYSTEMS CORP.Single Use Mechanical Lithotriptor BML-610A — OLYMPUS MEDICAL SYSTEMS CORP.COOK — COOK INCORPORATEDSingle Use Mechanical Lithotriptor V — OLYMPUS MEDICAL SYSTEMS CORP.Coil Sheath — OLYMPUS MEDICAL SYSTEMS CORP.Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.Soehendra — COOK INCORPORATEDTube Sheath — OLYMPUS MEDICAL SYSTEMS CORP.Trapezoid RX — BOSTON SCIENTIFIC CORPORATIONTrapezoid RX — BOSTON SCIENTIFIC CORPORATIONTrapezoid RX — BOSTON SCIENTIFIC CORPORATIONStrauss Surgical — AMERICAN MEDICAL ENDOSCOPY, INC.Single Use Mechanical Lithotriptor V — OLYMPUS MEDICAL SYSTEMS CORP.Basket Wire — OLYMPUS MEDICAL SYSTEMS CORP.Single Use BML Handle V — OLYMPUS MEDICAL SYSTEMS CORP.Single Use Mechanical Lithotriptor V — OLYMPUS MEDICAL SYSTEMS CORP.COIL SHEATH — OLYMPUS MEDICAL SYSTEMS CORP.Conquest TTC — COOK INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-16 | Olympus Corporation of the Americas | Potential for distal tip tearing of the Mechanical Lithotriptor V. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equ |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
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