510(k) Report

Devices descending from K082629

4 later devices reach S12X with Esax Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173684g.Estim PROG.Tec Medical Engineering GmbH20180—
+1K151354Cervello STIMBlackrock Neuromed20162—
+2K180761SD LTM STIM Cortical StimulatorMicromed S.P.A.20181—
+3K250094Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…Neuralynx, Inc.20250—