Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Devicor Medical Products, Inc.

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

Total Devices14
Categories2
Latest Approval2026-03-04
TypeNumberDevice NameCodeDate
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 Char KNW 2026-03-04 View
510(k) K253761 HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) NEU 2026-01-23 View
510(k) K243095 Mammotome AutoCore™ Single Insertion Core Biopsy System KNW 2024-10-29 View
510(k) K240527 HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) NEU 2024-07-10 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)) NEU 2024-01-12 View
510(k) K221961 HydroMARK Plus Breast Biopsy Site Marker NEU 2023-07-13 View
510(k) K212158 HydroMARK Breast Biopsy Site Marker NEU 2022-04-21 View
510(k) K210752 HydroMARK Breast Biopsy Site Marker NEU 2021-04-14 View
510(k) K203097 HydroMARK Breast Biopsy Site Markers NEU 2020-12-16 View
510(k) K202012 Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System KNW 2020-08-18 View
510(k) K170803 HydroMARK Breast Biopsy Site Markers NEU 2017-06-15 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 Stylet KNW 2016-08-08 View
510(k) K161021 HydroMARK Breast Biopsy Site Marker NEU 2016-05-05 View
510(k) K152989 Mammotome revolve Dual Vacuum Assist Biopsy System KNW 2016-02-25 View
↑