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Electronic Code of Federal Regulations

e-CFR data is current as of April 2, 2020

Title 21Chapter ISubchapter HPart 876Subpart E → §876.4500


Title 21: Food and Drugs
PART 876—GASTROENTEROLOGY-UROLOGY DEVICES
Subpart E—Surgical Devices


§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.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]

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