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Senorx, Inc.

FDA Regulatory Profile

Senorx, Inc. appears in FDA public data with 0 recalls, 30 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent FDA inspection ended on Sep 30, 2009 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Oct 27, 2023.

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Summary

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

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 30, 2009Irvine, CADevicesNo Action Indicated (NAI)3003167031

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233220EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI…Oct 27, 2023
K210654EnCor Breast Biopsy Probe with Rinse TubeMar 31, 2021
K161805EnCor MRI Introducer Set, EnCor Probe IntroducerJul 19, 2016
K131654STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERJun 27, 2013
K093512ENCOR BREAST BIOPSY SYSTEMNov 20, 2009
K092323CONTURA CAVITY MAINTENANCE CATHETERAug 19, 2009
K082264CONTURA LUMEN MARKERSep 12, 2008
K081085STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSAug 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 B011-45Apr 30, 2008
K080698GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGPMar 31, 2008
K072541SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEMSep 25, 2007
K071229SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPYMay 18, 2007
K052857ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000Oct 21, 2005
K051158ENCOR 7 GAUGEMay 16, 2005
K050090GEL MARK VFeb 7, 2005
K042098SENORX INTRODUCERAug 19, 2004
K040842SENORX BIOPSY DEVICE IIApr 30, 2004
K040706GEL MARK IVApr 8, 2004

FDA data resources