510(k) Report

Devices descending from K112411

3 later devices reach Mammotome Elite Biopsy System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc.20162—
+2K220595NeoNavia Biopsy SystemNeodynamics AB20220—
+2K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC20180—