Data / Medical devices / United States / Devicor Medical Products, Inc.
Devicor Medical Products, Inc.: FDA-registered device maker in Cincinnati, OH, United States, 20 510(k) clearances
Devicor Medical Products, Inc. is registered with the FDA (registration 3008492462) in Cincinnati, OH, United States. It lists 8 device types. The FDA files 20 510(k) clearances under its listings, the newest dated March 4, 2026. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008492462
- Address
- 300 E-Business Way Fifth Floor, Cincinnati, OH, United States, 45241
- Owner or operator
- Devicor Medical Products, Inc. (10033297)
- Roles
- Specification developer
- First device listed
- July 30, 2010
- Registered through
- 2026
- Brand names listed
- CorMARK¿ Biopsy Identifier, 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, MammoMark¿ Biopsy Identifier and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clip, Implantable | FZP | 2 | Specification developer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Specification developer | accessdata.fda.gov |
| Marker, Radiographic, Implantable | NEU | 2 | Specification developer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Specification developer | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | Specification developer | 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 |
| December 16, 2008 | K082278 | MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS | NEU | Substantially Equivalent | Ethicon Endo-Sugery, LLC | 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 |
| January 18, 2001 | K003297 | MAMMOTOME HAND HELD PROBE, MODEL MHH8 | KNW | Substantially Equivalent | Ethicon Endo-Surgery, Inc. | accessdata.fda.gov |
| November 18, 1999 | K992813 | 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT | 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 |
| March 28, 1997 | K970565 | MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) | KNW | Substantially Equivalent | Biopsys Medical, Inc. | accessdata.fda.gov |
| December 29, 1994 | K943863 | NEEDLE GUIDE | IYN | Substantially Equivalent | Biopsys Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2026 | 98843 | Class II | Ongoing | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. | accessdata.fda.gov |
| March 30, 2022 | 90119 | Class II | Terminated | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 | Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3. | accessdata.fda.gov |
| September 7, 2020 | 86228 | Class III | Terminated | Neoprobe GDS Control Unit, Model Number NPCU3 | It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01. | accessdata.fda.gov |
| February 28, 2017 | 76603 | Class II | Terminated | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance | The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number. | accessdata.fda.gov |
| May 19, 2016 | 74297 | Class II | Terminated | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. | accessdata.fda.gov |
Compare with other makers
- All makers of Drape, Surgical, Exempt
- All makers of Probe, Uptake, Nuclear
- All makers of Marker, Radiographic, Implantable
- All makers of Instrument, Biopsy
- All makers of Clip, Implantable
- All makers of Forceps, General & Plastic Surgery
Updated May 27, 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.