510(k) Report

Devices descending from K992813

9 later devices reach 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+1K030472Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemEthicon Endo-Surgery, Inc.20037—
+2K093512Encor Breast Biopsy SystemSenorx, Inc.20095—
+2K052246Modification to EN-Bloc Biopsy SystemNeothermia Corporation20050—
+3K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver…Senorx, Inc.20232—
+3K171890BEXCORE Breast Biopsy System, Biopsy NeedleMedical Park Co., Ltd.20180—
+3K111100Encor Enspire Breast Biopsy SystemC.R. Bard, Inc.20113—
+4K252681EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.202511
+5K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.20260—