Company · US
Devicor Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (2 in 12 months)
5recalls (1 in 12 months)
4recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 4, 2026 | K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted B Devicor Medical Products, Inc. | KNW |
| Jan 23, 2026 | K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shap Devicor Medical Products, Inc. | NEU |
| Oct 29, 2024 | K243095 | Mammotome AutoCore Single Insertion Core Biopsy System Devicor Medical Products, Inc. | KNW |
| Jul 10, 2024 | K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) Devicor Medical Products, Inc. | NEU |
| Jan 12, 2024 | K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Bi Devicor Medical Products, Inc. | NEU |
| Jul 13, 2023 | K221961 | HydroMARK Plus Breast Biopsy Site Marker Devicor Medical Products, Inc. | NEU |
| Apr 21, 2022 | K212158 | HydroMARK Breast Biopsy Site Marker Devicor Medical Products, Inc. | NEU |
| Apr 14, 2021 | K210752 | HydroMARK Breast Biopsy Site Marker Devicor Medical Products, Inc. | NEU |
| Dec 16, 2020 | K203097 | HydroMARK Breast Biopsy Site Markers Devicor Medical Products, Inc. | NEU |
| Aug 18, 2020 | K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System Devicor Medical Products, Inc. | KNW |
| Jun 15, 2017 | K170803 | HydroMARK Breast Biopsy Site Markers Devicor Medical Products, Inc. | NEU |
| Aug 8, 2016 | K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Devicor Medical Products, Inc. | KNW |
| May 5, 2016 | K161021 | HydroMARK Breast Biopsy Site Marker Devicor Medical Products, Inc. | NEU |
| Feb 25, 2016 | K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System Devicor Medical Products, Inc. | KNW |
| Nov 15, 2012 | K123259 | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM Devicor Medical Products, Inc. | KNW |
| Mar 20, 2012 | K112411 | MAMMOTOME ELITE BIOPSY SYSTEM Devicor Medical Products, Inc. | KNW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2026 | Devicor Medical Products Inc HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Open, Classified |
NEU | K212158 |
| Mar 30, 2022 | Devicor Medical Products Inc HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 Terminated |
NEU | K210752 |
| Sep 7, 2020 | Devicor Medical Products Inc Neoprobe GDS Control Unit, Model Number NPCU3 Terminated |
IZD | None listed |
| Mar 8, 2017 | Devicor Medical Products Inc Mammotome Revolve Dual Vacuum Assist Biopsy
System
The device is used to sample breast tissue that has been identified as suspicious under imaging guidance Terminated |
KNW | K152989 |
| Jul 14, 2016 | Devicor Medical Products Inc Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graph Terminated |
OIJ | K123259 |