510(k) Report

Devices descending from K033700

10 later devices reach Mammotome EX Hand Held System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152989Mammotome revolve Dual Vacuum Assist Biopsy SystemDevicor Medical Products, Inc.201611
+1K123259Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemDevicor Medical Products, Inc.201221
+1K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc.20123—
+1K080095Coramate/Spirotome SystemMedinvents200811
+1K060384Coramate/Spirotome SystemMedinvents200621
+2K202012Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemDevicor Medical Products, Inc.20200—
+2K190378Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…Bioncise NV20190—
+2K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc.20162—
+3K220595NeoNavia Biopsy SystemNeodynamics AB20220—
+3K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC20180—