Data / Medical devices / United States / Devicor Medical Products, Inc. Warehouse/Distribution/Service Center
Devicor Medical Products, Inc. Warehouse/Distribution/Service Center: FDA-registered device maker in Blue Ash, OH, United States, 15 510(k) clearances
Devicor Medical Products, Inc. Warehouse/Distribution/Service Center is registered with the FDA (registration 3010339638) in Blue Ash, OH, United States. It lists 2 device types. The FDA files 15 510(k) clearances under its listings, the newest dated March 4, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010339638
- Address
- 4750 Lake Forest Dr Ste 120, Blue Ash, OH, United States, 45242
- Owner or operator
- Devicor Medical Products, Inc. (10033297)
- Roles
- Remanufacturer, Repackager or relabeler
- First device listed
- July 30, 2010
- Registered through
- 2026
- Brand names listed
- HydroMARK Plus, HydroMARK Plus Breast Biopsy Site Marker, HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape), HydroMark Breast Biopsy Site Marker, Hydromark, LumiMARK Biopsy Site Marker, Mammotome AutoCore Single Insertion Core Biopsy System, Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Biopsy | KNW | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 4, 2026 | 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 | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| January 23, 2026 | K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| October 29, 2024 | K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | KNW | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| July 10, 2024 | K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| January 12, 2024 | K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| July 13, 2023 | K221961 | HydroMARK Plus Breast Biopsy Site Marker | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| April 21, 2022 | K212158 | HydroMARK Breast Biopsy Site Marker | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| April 14, 2021 | K210752 | HydroMARK Breast Biopsy Site Marker | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| December 16, 2020 | K203097 | HydroMARK Breast Biopsy Site Markers | NEU | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| August 18, 2020 | K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | KNW | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| August 8, 2016 | 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 | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| February 25, 2016 | K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System | KNW | Substantially Equivalent | Devicor Medical Products, Inc. | accessdata.fda.gov |
| November 8, 2004 | K042753 | MAMMOTOME MR BIOPSY SYSTEM | KNW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| February 20, 2004 | K033700 | MAMMOTOME EX HAND HELD SYSTEM | KNW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| August 17, 1999 | K991980 | MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, | KNW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.