Senorx, Inc.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Senorx, Inc.” (first 2000, latest 2023), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 22 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 21 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 18 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 27 |
| 2022 | 0 | — |
| 2023 | 1 | 29 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Senorx, Inc. took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 9 | 9 |
| NEU | Marker, Radiographic, Implantable | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 5 | 5 |
| FZP | Clip, Implantable | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- General and Plastic Surgery (24)
- Radiology (6)
Most recent Senorx, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233220 | EnCor EnspireBreast 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 | 29 |
| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | KNW | 2021-03-31 | 27 |
| K161805 | EnCor MRI Introducer Set, EnCor Probe Introducer | KNW | 2016-07-19 | 18 |
| K131654 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | NEU | 2013-06-27 | 21 |
| K093512 | ENCOR BREAST BIOPSY SYSTEM | KNW | 2009-11-20 | 7 |
| K092323 | CONTURA CAVITY MAINTENANCE CATHETER | JAQ | 2009-08-19 | 15 |
| K082264 | CONTURA LUMEN MARKER | JAQ | 2008-09-12 | 32 |
| K081085 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | NEU | 2008-08-01 | 107 |
| K081170 | PROSTATE TISSUE MARKER | NEU | 2008-05-28 | 34 |
| K081079 | CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY | JAQ | 2008-05-02 | 16 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Senorx, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Senorx, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Senorx, Inc.?
FDA lists 30 510(k) clearances under the applicant name “Senorx, Inc.” (first 2000, latest 2023), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Senorx, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Senorx, Inc. is 22 days.
Which FDA product codes appear under Senorx, Inc.?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 9); NEU (Marker, Radiographic, Implantable, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6).
Next steps
- See all 30 Senorx, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNW, Senorx, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.