---
kind: "section"
citation: "21 C.F.R. § 876.4500"
title: "21"
number: "876.4500"
heading: "Mechanical lithotriptor."
url: "https://uscodex.org/cfr/21/876.4500"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 876.9](/cfr/21/876.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

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