510(k) Report

Devices descending from K970565

7 later devices reach Mammotome Biopsy Probe and Housing (Mammotome) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024089Vacuflash Biopsy SystemBip USA, Inc.20034—
+1K020024Caris Minitome Biopsy InstrumentArtemis Medical, Inc.20020—
+1K973496The Auto Suture* Mibb** SystemUnited States Surgical, A Division of Tyco Healthc19970—
+2K173316SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…Transmed7, LLC20180—
+2K053151Rubicor Magic Breast Biopsy DeviceRubicor Medical, Inc.20053—
+3K071048Rubicor Magic Breast Biopsy Device, Model 31537Rubicor Medical, Inc.20071—
+4K133702Presto Breast Biopsy DeviceSontina Medical, LLC20140—