510(k) Report

Devices descending from K964112

202 later devices reach Berenstein Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+12K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—