---
kind: "section"
citation: "21 C.F.R. § 876.4480"
title: "21"
number: "876.4480"
heading: "Electrohydraulic lithotriptor."
url: "https://uscodex.org/cfr/21/876.4480"
---

# §876.4480. Electrohydraulic lithotriptor.

- (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.”

## Notes

### Amendments

[48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]

### 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 52 FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, 2000]