510(k) Report

Devices descending from K181465

5 later devices reach SpaceOAR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202224SpaceOAR SystemBoston Scientific Corporation202011
+1K182971SpaceOAR Vue HydrogelAugmenix, Inc.201921
+2K262151SpaceOAR Flex™ SystemBoston Scientific Corporation20260—
+2K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation20260—
+2K220641Barrigel Injectable GelPalette Life Sciences20220—