510(k) Report

Devices descending from K191083

3 later devices reach COMPLETE CONTROL System Gen2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223738Alpha Control Liner System (ACLS)Coapt20232—
+2K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl20251—
+3K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl20260—