510(k) Report

Devices descending from K103359

2 later devices reach Finesse Ultra Breast Biopsy System Driver (Blue, Pink) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192948EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…Bard Peripheral Vascular, Inc.20191—
+2K211933EleVation Breast Biopsy SystemBard Peripheral Vascular20210—