Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule.
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.
D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D005762:Gastroenterology / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D008096:Lithotripsy / Q000145:classification / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration; D014572:Urology / Q000145:classification / Q000295:instrumentation*