510(k) Report

Devices descending from K030472

7 later devices reach Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093512Encor Breast Biopsy SystemSenorx, Inc.20095—
+1K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation20050—
+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—