510(k) Report

Devices descending from K050737

2 later devices reach Neothermia EN-Bloc Biopsy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102756Surecore Biopsy DeviceChest Innovations, Inc.20110—
+1K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation20050—