Gastroenterology and Urology Devices; Reclassification of the Extracorporeal Shock Wave Lithotripter
Information
Type
Rule
Regulated products
Published
August 9, 2000
Last updated
August 9, 2000
Description
Document number 00-20089. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)