Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of HologicLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list SenoRx with 30 510(k) clearances. The most recent is a 510(k) clearance dated Oct 27, 2023: EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR)….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 27, 2023 | 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)K233220 · KNW | 510(k) clearances |
| Mar 31, 2021 | EnCor Breast Biopsy Probe with Rinse TubeK210654 · KNW | 510(k) clearances |
| Jul 19, 2016 | EnCor MRI Introducer Set, EnCor Probe IntroducerK161805 · KNW | 510(k) clearances |
| Jun 27, 2013 | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKERK131654 · NEU | 510(k) clearances |
| Nov 20, 2009 | ENCOR BREAST BIOPSY SYSTEMK093512 · KNW | 510(k) clearances |
| Aug 19, 2009 | CONTURA CAVITY MAINTENANCE CATHETERK092323 · JAQ | 510(k) clearances |
| Sep 12, 2008 | CONTURA LUMEN MARKERK082264 · JAQ | 510(k) clearances |
| Aug 1, 2008 | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSK081085 · NEU | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
