Senorx, Inc.
Irvine, CA, US
Senorx, Inc. appears in FDA device records in Irvine, CA. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Senorx, Inc. between 2000 and 2023. The busiest year on record is 2008, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 3 |
| 2007 | 2 |
| 2008 | 6 |
| 2009 | 2 |
| 2013 | 1 |
| 2016 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | Substantially Equivalent | |
| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | KNW | Substantially Equivalent | |
| K161805 | EnCor MRI Introducer Set, EnCor Probe Introducer | KNW | Substantially Equivalent | |
| K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | NEU | Substantially Equivalent | |
| K093512 | ENCOR BREAST BIOPSY SYSTEM | KNW | Substantially Equivalent | |
| K092323 | CONTURA CAVITY MAINTENANCE CATHETER | JAQ | Substantially Equivalent | |
| K082264 | CONTURA LUMEN MARKER | JAQ | Unknown | |
| K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | NEU | Substantially Equivalent | |
| K081170 | PROSTATE TISSUE MARKER | NEU | Substantially Equivalent | |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | JAQ | Unknown | |
| K080791 | CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 | JAQ | Unknown | |
| K080698 | GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP | NEU | Substantially Equivalent | |
| K072541 | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM | ITX | Substantially Equivalent | |
| K071229 | SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY | JAQ | Unknown | |
| K052857 | ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000 | GEI | Substantially Equivalent | |
| K051158 | ENCOR 7 GAUGE | KNW | Substantially Equivalent | |
| K050090 | GEL MARK V | NEU | Substantially Equivalent | |
| K042098 | SENORX INTRODUCER | GEI | Substantially Equivalent | |
| K040842 | SENORX BIOPSY DEVICE II | KNW | Substantially Equivalent | |
| K040706 | GEL MARK IV | NEU | Substantially Equivalent | |
| K031938 | GEL MARK III BIOPSY SITE MARKER | NEU | Substantially Equivalent | |
| K030473 | SENORX ES-300 | GEI | Substantially Equivalent | |
| K023923 | SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE | KNW | Substantially Equivalent | |
| K021707 | SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS | KNW | Substantially Equivalent | |
| K013641 | SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS | GEI | Substantially Equivalent | |
| K012004 | EASY GUIDE ELECTROSURGICAL ACCESS DEVICE | GEI | Substantially Equivalent | |
| K012023 | ANCHOR GUIDE LESION LOCALIZATION DEVICE; ANCOR GUIDE HOLDER; RF GENERATOR CABLE | KNW | Substantially Equivalent | |
| K012799 | ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL | GEI | Substantially Equivalent | |
| K011402 | BIOPSY SITE MARKER | FZP | Substantially Equivalent | |
| K000060 | GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007 | GDW | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain