Senorx, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRIOctober 27, 2023
K210654EnCor Breast Biopsy Probe with Rinse TubeMarch 31, 2021
K161805EnCor MRI Introducer Set, EnCor Probe IntroducerJuly 19, 2016
K131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERJune 27, 2013
K093512ENCOR BREAST BIOPSY SYSTEMNovember 20, 2009
K092323CONTURA CAVITY MAINTENANCE CATHETERAugust 19, 2009
K082264CONTURA LUMEN MARKERSeptember 12, 2008
K081085STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSAugust 1, 2008
K081170PROSTATE TISSUE MARKERMay 28, 2008
K081079CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPYMay 2, 2008
K080791CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45April 30, 2008
K080698GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGPMarch 31, 2008
K072541SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEMSeptember 25, 2007
K071229SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPYMay 18, 2007
K052857ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000October 21, 2005
K051158ENCOR 7 GAUGEMay 16, 2005
K050090GEL MARK VFebruary 7, 2005
K042098SENORX INTRODUCERAugust 19, 2004
K040842SENORX BIOPSY DEVICE IIApril 30, 2004
K040706GEL MARK IVApril 8, 2004