Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Senorx, Inc. — Predicate Candidate Screening

30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

24 daysmedian FDA review time

85 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K233220	EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Br	Senorx, Inc.	2023-10-27	29
K210654	EnCor Breast Biopsy Probe with Rinse Tube	Senorx, Inc.	2021-03-31	27
K161805	EnCor MRI Introducer Set, EnCor Probe Introducer	Senorx, Inc.	2016-07-19	18
K131654	STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST	Senorx, Inc.	2013-06-27	21
K093512	ENCOR BREAST BIOPSY SYSTEM	Senorx, Inc.	2009-11-20	7
K092323	CONTURA CAVITY MAINTENANCE CATHETER	Senorx, Inc.	2009-08-19	15
K082264	CONTURA LUMEN MARKER	Senorx, Inc.	2008-09-12	32
K081085	STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10	Senorx, Inc.	2008-08-01	107
K081170	PROSTATE TISSUE MARKER	Senorx, Inc.	2008-05-28	34
K081079	CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY	Senorx, Inc.	2008-05-02	16
K080791	CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHER	Senorx, Inc.	2008-04-30	41
K080698	GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP	Senorx, Inc.	2008-03-31	19
K072541	SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM	Senorx, Inc.	2007-09-25	15
K071229	SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHE	Senorx, Inc.	2007-05-18	15
K052857	ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000	Senorx, Inc.	2005-10-21	10
K051158	ENCOR 7 GAUGE	Senorx, Inc.	2005-05-16	11
K050090	GEL MARK V	Senorx, Inc.	2005-02-07	24
K042098	SENORX INTRODUCER	Senorx, Inc.	2004-08-19	15
K040842	SENORX BIOPSY DEVICE II	Senorx, Inc.	2004-04-30	29
K040706	GEL MARK IV	Senorx, Inc.	2004-04-08	21
K031938	GEL MARK III BIOPSY SITE MARKER	Senorx, Inc.	2003-09-05	74
K030473	SENORX ES-300	Senorx, Inc.	2003-02-26	14
K023923	SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8	Senorx, Inc.	2002-12-11	16
K021707	SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SING	Senorx, Inc.	2002-08-14	83
K013641	SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCE	Senorx, Inc.	2002-01-29	85
K012004	EASY GUIDE ELECTROSURGICAL ACCESS DEVICE	Senorx, Inc.	2001-09-25	90
K012023	ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER;	Senorx, Inc.	2001-09-12	76
K012799	ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL	Senorx, Inc.	2001-09-04	14
K011402	BIOPSY SITE MARKER	Senorx, Inc.	2001-07-16	70
K000060	GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007	Senorx, Inc.	2000-03-27	77

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda