510(k) Report

Devices descending from K090611

2 later devices reach Revolution Full Core Biopsy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243886ExpressCore Biopsy DeviceInrad, Inc.20250—
+1K112945Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM…Inrad, Inc.201101