510(k) Report

Devices descending from K101482

2 later devices reach EM-9000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG20250—
+1K131721Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1Comed Medical Systems Co., Ltd.20140—