Devicor Medical Products Inc
Cincinnati, OH, US
DEVICOR MEDICAL PRODUCTS, INC. appears in FDA device records in Cincinnati, OH. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Devicor Medical Products Inc between 2012 and 2026. The busiest year on record is 2016, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 2 |
| 2016 | 3 |
| 2017 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) | NEU | Substantially Equivalent | |
| K243095 | Mammotome AutoCore™ Single Insertion Core Biopsy System | KNW | Substantially Equivalent | |
| K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | NEU | Substantially Equivalent | |
| 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 | |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | NEU | Substantially Equivalent | |
| K212158 | HydroMARK Breast Biopsy Site Marker | NEU | Substantially Equivalent | |
| K210752 | HydroMARK Breast Biopsy Site Marker | NEU | Substantially Equivalent | |
| K203097 | HydroMARK Breast Biopsy Site Markers | NEU | Substantially Equivalent | |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | KNW | Substantially Equivalent | |
| K170803 | HydroMARK Breast Biopsy Site Markers | NEU | Substantially Equivalent | |
| 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 | |
| K161021 | HydroMARK Breast Biopsy Site Marker | NEU | Substantially Equivalent | |
| K152989 | Mammotome revolve Dual Vacuum Assist Biopsy System | KNW | Substantially Equivalent | |
| K123259 | MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM | KNW | Substantially Equivalent | |
| K112411 | MAMMOTOME ELITE BIOPSY SYSTEM | KNW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008492462 | 3008492462 | DEVICOR MEDICAL PRODUCTS, INC. | 300 E-Business Way, Cincinnati, OH 45241 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2239-2026 | 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. | Class II | Open, Classified | |
| Z-1124-2022 | 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. | Class II | Terminated | |
| Z-0070-2021 | 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. | Class III | Terminated | |
| Z-1512-2017 | 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. | Class II | Terminated | |
| Z-2211-2016 | 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 tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. | A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain