510(k) Report

Devices descending from K020031

1 later device reach EN-Bloc Biopsy System, Models 777-110, 777-120, 770-001, 777002, 777-006… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation20050—