FDA 510(k) Applications Submitted by Kathryn Swanstrom

FDA 510(k) Number Submission Date Device Name Applicant
K233220 09/28/2023 EnCor EnspireÖBreast Biopsy System (E4115, E4230); EnCorÖ Breast Biopsy Driver (DRENCOR); EnCorÖ MRI Breast Biopsy Driver (DRENCORMR); EnCorÖ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCorÖ MRI Breast Biop SenoRx, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact