FDA 510(k) Applications Submitted by DEVICOR MEDICAL PRODUCTS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210752 |
03/15/2021 |
HydroMARK Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
| K212158 |
07/12/2021 |
HydroMARK Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
| K243095 |
09/30/2024 |
Mammotome AutoCoreÖ Single Insertion Core Biopsy System |
Devicor Medical Products, Inc. |
| K202012 |
07/21/2020 |
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System |
Devicor Medical Products, Inc. |
| K240527 |
02/23/2024 |
HydroMARKÖ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) |
Devicor Medical Products, Inc. |
| K221961 |
07/05/2022 |
HydroMARK Plus Breast Biopsy Site Marker |
Devicor Medical Products, Inc. |
| K232615 |
08/28/2023 |
LumiMARKÖ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARKÖ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARKÖ Biopsy Site Marker (LM0215R (Rose shape)) |
Devicor Medical Products, Inc. |
| K170803 |
03/17/2017 |
HydroMARK Breast Biopsy Site Markers |
Devicor Medical Products, Inc. |
| K161021 |
04/12/2016 |
HydroMARK Breast Biopsy Site Marker |
DEVICOR MEDICAL PRODUCTS, INC. |
| K153709 |
12/23/2015 |
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 |
DEVICOR MEDICAL PRODUCTS, INC. |
| K123259 |
10/18/2012 |
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM |
DEVICOR MEDICAL PRODUCTS, INC. |
| K152989 |
10/13/2015 |
Mammotome revolve Dual Vacuum Assist Biopsy System |
DEVICOR MEDICAL PRODUCTS, INC. |
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