Zdrowie i gospodarka · 09/08/2000

FDA Reclassifies Extracorporeal Shock Wave Lithotripter for Kidney Stone Treatment

The Food and Drug Administration (FDA) is issuing a final rule to reclassify the extracorporeal shock wave lithotripter from class III to class II for use in fragmenting kidney and ureteral stones, aiming to ensure the device's safety and effectiveness. The FDA is taking this action on its own initiative.