510(k) Report

Devices descending from K930629

7 later devices reach Acryl-X II System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990572SonotomeSonokinetics, Inc.19996—
+2K152699Apollo SystemPenumbra, Inc.20164—
+2K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies19990—
+3K181731MR Compatible Aspiration KitMri Interventions, Inc.20180—
+3K171332Artemis Neuro Evacuation DevicePenumbra, Inc.20172—
+4K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical20201—
+5K230125Neuroblade SystemClearmind Biomedical20230—