510(k) Report

Devices descending from K242582

2 later devices reach Optima Coil System (OptiBlock Line Extension) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+2K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—