510(k) Report

Devices descending from DEN140030

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222972BioProtect Balloon Implant™ SystemBioprotect, Ltd.20230—
+1K182971SpaceOAR Vue HydrogelAugmenix, Inc.201921
+1K181465SpaceOAR SystemAugmenix, Inc.201851
+2K262151SpaceOAR Flex™ SystemBoston Scientific Corporation20260—
+2K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation20260—
+2K202224SpaceOAR SystemBoston Scientific Corporation202011
+3K220641Barrigel Injectable GelPalette Life Sciences20220—