510(k) Report

Devices descending from K003297

27 later devices reach Mammotome Hand Held Probe, Model MHH8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133702Presto Breast Biopsy DeviceSontina Medical, LLC20140—
+1K093512Encor Breast Biopsy SystemSenorx, Inc.20095—
+1K093068Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USC.R. Bard, Inc.20097—
+1K060413Intact Breast Lesion Excision System and AdvanceIntact Medical Corporation20064—
+1K040087RabbitScion International, Inc.20040—
+1K024089Vacuflash Biopsy SystemBip USA, Inc.20034—
+1K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc.20020—
+1K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power…Senorx, Inc.20021—
+2K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc.20232—
+2K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd.20180—
+2K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC20180—
+2K142477Intact Advance and Intact Excision XL, Intact BLESIntact Medical Corporation20142—
+2K112411Mammotome Elite Biopsy SystemDevicor Medical Products, Inc.20123—
+2K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc.20113—
+2K103359Finesse Ultra Breast Biopsy System Driver (Blue, Pink)C.R. Bard, Inc.20102—
+2K081057Intact Breast Lesion Excision System with Intact Excision XLIntact Medical Corporation20083—
+2K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.20053—
+2K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc.20020—
+3K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.202511
+3K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…Bard Peripheral Vascular, Inc.20191—
+3K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…Devicor Medical Products, Inc.20162—
+3K152596Intact® Gen2 SystemIntact Medical Corporation20161—
+3K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc.20071—
+4K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.20260—
+4K252183Resitu Slider 09 (RESL09)Resitu Medical AB20250—
+4K220595NeoNavia Biopsy SystemNeodynamics AB20220—
+4K211933EleVation Breast Biopsy SystemBard Peripheral Vascular20210—