Devicor Medical Products, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module, HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape), Mammotome AutoCore™ Single Insertion Core Biopsy System
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Devicor Medical Products, Inc. General & Plastic Surgery ✕
12 devices
Cleared
Mar 04, 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
General & Plastic Surgery
28d
Cleared
Jan 23, 2026
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)
General & Plastic Surgery
59d
Cleared
Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
General & Plastic Surgery
29d
Cleared
Jul 10, 2024
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
General & Plastic Surgery
138d
Cleared
Jan 12, 2024
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape))
General & Plastic Surgery
137d
Cleared
Jul 13, 2023
HydroMARK Plus Breast Biopsy Site Marker
General & Plastic Surgery
373d
Cleared
Apr 21, 2022
HydroMARK Breast Biopsy Site Marker
General & Plastic Surgery
283d
Cleared
Apr 14, 2021
HydroMARK Breast Biopsy Site Marker
General & Plastic Surgery
30d
Cleared
Dec 16, 2020
HydroMARK Breast Biopsy Site Markers
General & Plastic Surgery
63d
Cleared
Aug 18, 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
General & Plastic Surgery
28d
Cleared
Jun 15, 2017
HydroMARK Breast Biopsy Site Markers
General & Plastic Surgery
90d
Cleared
May 05, 2016
HydroMARK Breast Biopsy Site Marker
General & Plastic Surgery
23d