WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR

• K Number: K011178
• Device Name: WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
• Manufacturer: WILSON-COOK MEDICAL, INC.
• Date Cleared: 2001-05-04 ( 17 days)
• Product Code: LQC
• Regulation Number: 876.4500
• Type: Special
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 876.4500 Mechanical lithotriptor.

(a)
Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.(b)
Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.