510(k) Report

Devices descending from K182971

2 later devices reach SpaceOAR Vue Hydrogel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262151SpaceOAR Flex™ SystemBoston Scientific Corporation20260—
+1K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation20260—