# Gastroenterology and Urology Devices; Reclassification of the Extracorporeal Shock Wave Lithotripter
> **Food and Drug Administration** · Final rule. · Published 2000-08-09 · Effective 2000-09-08 · 65 FR 48609
## Document
- **Document number:** 00-20089
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 48609
- **CFR reference:** 21 CFR 876
- **Publication date:** 2000-08-09
- **Effective date:** 2000-09-08
- **HHS docket:** Docket No. 98N-1134
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document, which will serve as the special control for the reclassified device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/08/09/00-20089/gastroenterology-and-urology-devices-reclassification-of-the-extracorporeal-shock-wave-lithotripter)
---
*AI Analytics · CC0 1.0*