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Devicor Medical Products, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories2
Latest FDA decision2026-03-04
TypeNumberDevice NameCodeDateActions
510(k) K260365 Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharKNW2026-03-04 View
510(k) K253761 HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)NEU2026-01-23 View
510(k) K243095 Mammotome AutoCore™ Single Insertion Core Biopsy SystemKNW2024-10-29 View
510(k) K240527 HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)NEU2024-07-10 View
510(k) K232615 LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))NEU2024-01-12 View
510(k) K221961 HydroMARK Plus Breast Biopsy Site MarkerNEU2023-07-13 View
510(k) K212158 HydroMARK Breast Biopsy Site MarkerNEU2022-04-21 View
510(k) K210752 HydroMARK Breast Biopsy Site MarkerNEU2021-04-14 View
510(k) K203097 HydroMARK Breast Biopsy Site MarkersNEU2020-12-16 View
510(k) K202012 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemKNW2020-08-18 View
510(k) K170803 HydroMARK Breast Biopsy Site MarkersNEU2017-06-15 View
510(k) K153709 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletKNW2016-08-08 View
510(k) K161021 HydroMARK Breast Biopsy Site MarkerNEU2016-05-05 View
510(k) K152989 Mammotome revolve Dual Vacuum Assist Biopsy SystemKNW2016-02-25 View
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