§ 876.4480. Electrohydraulic lithotriptor.
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/us/cfr/t21/s§ 876.4480·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.
(b)Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.” [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]
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§ 876.4480
Electrohydraulic lithotriptor.
Fed. Reg.×1
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