Medical Device Manufacturer · US , Cincinnati , OH

Devicor Medical Products, Inc.

16 submissions · 16 cleared · Since 2012
16
Total
16
Cleared
0
Denied

Devicor Medical Products, Inc. — FDA 510(k) Submissions

Devicor Medical Products, Inc. has submitted 16 FDA 510(k) premarket notifications since 2012, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Marker, Radiographic, Implantable, Instrument, Biopsy . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
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
K260365 · KNW Instrument, Biopsy · General & Plastic Surgery
Mar 2026 28d
HydroMARK? Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape)
K253761 · NEU Marker, Radiographic,... · General & Plastic Surgery
Jan 2026 59d
Mammotome AutoCore? Single Insertion Core Biopsy System
K243095 · KNW Instrument, Biopsy · General & Plastic Surgery
Oct 2024 29d
HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
K240527 · NEU Marker, Radiographic,... · General & Plastic Surgery
Jul 2024 138d
LumiMARK? Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK? Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK? Biopsy Site Marker (LM0215R (Rose shape))
K232615 · NEU Marker, Radiographic,... · General & Plastic Surgery
Jan 2024 137d
HydroMARK Plus Breast Biopsy Site Marker
K221961 · NEU Marker, Radiographic,... · General & Plastic Surgery
Jul 2023 373d
HydroMARK Breast Biopsy Site Marker
K212158 · NEU Marker, Radiographic,... · General & Plastic Surgery
Apr 2022 283d
HydroMARK Breast Biopsy Site Marker
K210752 · NEU Marker, Radiographic,... · General & Plastic Surgery
Apr 2021 30d
HydroMARK Breast Biopsy Site Markers
K203097 · NEU Marker, Radiographic,... · General & Plastic Surgery
Dec 2020 63d
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · KNW Instrument, Biopsy · General & Plastic Surgery
Aug 2020 28d
HydroMARK Breast Biopsy Site Markers
K170803 · NEU Marker, Radiographic,... · General & Plastic Surgery
Jun 2017 90d
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
K153709 · KNW Instrument, Biopsy · Gastroenterology & Urology
Aug 2016 229d
HydroMARK Breast Biopsy Site Marker
K161021 · NEU Marker, Radiographic,... · General & Plastic Surgery
May 2016 23d
Mammotome revolve Dual Vacuum Assist Biopsy System
K152989 · KNW Instrument, Biopsy · Gastroenterology & Urology
Feb 2016 135d
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
K123259 · KNW Instrument, Biopsy · Gastroenterology & Urology
Nov 2012 28d
MAMMOTOME ELITE BIOPSY SYSTEM
K112411 · KNW Instrument, Biopsy · Gastroenterology & Urology
Mar 2012 211d
Filters