510(k) Report

Devices descending from K213385

3 later devices reach GEM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242507OBSIDIO™ Conformable EmbolicBoston Scientific20242—
+2K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation20260—
+2K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation20250—