21 CFR § 876.4500 - Mechanical lithotriptor.

---
identifier: "/us/cfr/t21/s876.4500"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.4500 - Mechanical lithotriptor."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.4500"
section_name: "Mechanical lithotriptor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 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]