510(k) Report

Devices descending from K040842

7 later devices reach Senorx Biopsy Device II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093512Encor Breast Biopsy SystemSenorx, Inc.20095—
+1K072541Senosonix Ultrasound Breast Biopsy SystemSenorx, Inc.20070—
+2K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc.20232—
+2K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd.20180—
+2K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc.20113—
+3K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.202511
+4K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.20260—