Senorx, Inc.

FDA 510(k) & PMA Approved Devices — 30 products

Total Devices30

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K233220	EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)	KNW	2023-10-27	View
510(k)	K210654	EnCor Breast Biopsy Probe with Rinse Tube	KNW	2021-03-31	View
510(k)	K161805	EnCor MRI Introducer Set, EnCor Probe Introducer	KNW	2016-07-19	View
510(k)	K131654	STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER	NEU	2013-06-27	View
510(k)	K093512	ENCOR BREAST BIOPSY SYSTEM	KNW	2009-11-20	View
510(k)	K092323	CONTURA CAVITY MAINTENANCE CATHETER	JAQ	2009-08-19	View
510(k)	K082264	CONTURA LUMEN MARKER	JAQ	2008-09-12	View
510(k)	K081085	STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS	NEU	2008-08-01	View
510(k)	K081170	PROSTATE TISSUE MARKER	NEU	2008-05-28	View
510(k)	K081079	CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY	JAQ	2008-05-02	View
510(k)	K080791	CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45	JAQ	2008-04-30	View
510(k)	K080698	GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP	NEU	2008-03-31	View
510(k)	K072541	SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM	ITX	2007-09-25	View
510(k)	K071229	SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY	JAQ	2007-05-18	View
510(k)	K052857	ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000	GEI	2005-10-21	View
510(k)	K051158	ENCOR 7 GAUGE	KNW	2005-05-16	View
510(k)	K050090	GEL MARK V	NEU	2005-02-07	View
510(k)	K042098	SENORX INTRODUCER	GEI	2004-08-19	View
510(k)	K040842	SENORX BIOPSY DEVICE II	KNW	2004-04-30	View
510(k)	K040706	GEL MARK IV	NEU	2004-04-08	View