Medical Device Manufacturer · US , Cincinnati , OH

Devicor Medical Products, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2012

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

Devicor Medical Products, Inc. has 16 FDA 510(k) cleared general & plastic surgery devices. Based in Cincinnati, US.

Latest FDA clearance: Mar 2026. Active since 2012.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Devicor Medical Products, Inc.

16 devices
1-16 of 16
Cleared Mar 04, 2026
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · KNW
General & Plastic Surgery · 28d
Cleared Jan 23, 2026
HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape)
K253761 · NEU
General & Plastic Surgery · 59d
Cleared Oct 29, 2024
Mammotome AutoCore™ Single Insertion Core Biopsy System
K243095 · KNW
General & Plastic Surgery · 29d
Cleared Jul 10, 2024
HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
K240527 · NEU
General & Plastic Surgery · 138d
Cleared Jan 12, 2024
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape))
K232615 · NEU
General & Plastic Surgery · 137d
Cleared Jul 13, 2023
HydroMARK Plus Breast Biopsy Site Marker
K221961 · NEU
General & Plastic Surgery · 373d
Cleared Apr 21, 2022
HydroMARK Breast Biopsy Site Marker
K212158 · NEU
General & Plastic Surgery · 283d
Cleared Apr 14, 2021
HydroMARK Breast Biopsy Site Marker
K210752 · NEU
General & Plastic Surgery · 30d
Cleared Dec 16, 2020
HydroMARK Breast Biopsy Site Markers
K203097 · NEU
General & Plastic Surgery · 63d
Cleared Aug 18, 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · KNW
General & Plastic Surgery · 28d
Cleared Jun 15, 2017
HydroMARK Breast Biopsy Site Markers
K170803 · NEU
General & Plastic Surgery · 90d
Cleared Aug 08, 2016
Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G...
K153709 · KNW
Gastroenterology & Urology · 229d
Cleared May 05, 2016
HydroMARK Breast Biopsy Site Marker
K161021 · NEU
General & Plastic Surgery · 23d
Cleared Feb 25, 2016
Mammotome revolve Dual Vacuum Assist Biopsy System
K152989 · KNW
Gastroenterology & Urology · 135d
Cleared Nov 15, 2012
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
K123259 · KNW
Gastroenterology & Urology · 28d
Cleared Mar 20, 2012
MAMMOTOME ELITE BIOPSY SYSTEM
K112411 · KNW
Gastroenterology & Urology · 211d
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