Devicor Medical Products Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 16
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1124-2022 | Class II | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | March 30, 2022 |
| Z-0070-2021 | Class III | Neoprobe GDS Control Unit, Model Number NPCU3 | September 7, 2020 |
| Z-1512-2017 | Class II | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue tha | February 28, 2017 |
| Z-2211-2016 | Class II | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable | May 19, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Du | March 4, 2026 |
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Mark | January 23, 2026 |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | October 29, 2024 |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | July 10, 2024 |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus S | January 12, 2024 |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | July 13, 2023 |
| K212158 | HydroMARK Breast Biopsy Site Marker | April 21, 2022 |
| K210752 | HydroMARK Breast Biopsy Site Marker | April 14, 2021 |
| K203097 | HydroMARK Breast Biopsy Site Markers | December 16, 2020 |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | August 18, 2020 |
| K170803 | HydroMARK Breast Biopsy Site Markers | June 15, 2017 |
| K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Bi | August 8, 2016 |
| K161021 | HydroMARK Breast Biopsy Site Marker | May 5, 2016 |
| K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System | February 25, 2016 |
| K123259 | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM | November 15, 2012 |
| K112411 | MAMMOTOME ELITE BIOPSY SYSTEM | March 20, 2012 |