Mammotome HydroMARK
HydroMARK Breast Biopsy Site Marker- CE Mark
1manufacturer
8catalogue numbers in this listing
9510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Devicor Medical Products, Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K203097 |
| Record published | 2022-03-02 |
| Record revised | 2026-06-19 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 25 °C |
| Packaging | Pack of 10 |
| Sizes | Needle gauge 9 G |
| Distribution end date | 2022-02-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CA000520002 | In distribution | |
| CA000515003 | In distribution | |
| CA000520003 | In distribution | |
| CA000520001 | In distribution | |
| CA000515001 | In distribution | |
| CA000515002 | In distribution | |
| 4010-03-09-T3 | Needle Gauge 9 G | Withdrawn |
| 4010-03-09-T1 | Needle Gauge 9 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydroMARK | Devicor Medical Products, Inc. | 75 |
| Scout® | Merit Medical Systems, Inc. | 68 |
| Scout MD™ | Merit Medical Systems, Inc. | 46 |
| SmartClip | Elucent Medical Inc. | 37 |
| BiomarC® | Carbon Medical Technologies, Inc. | 25 |
| HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 21 |
| SecurMark | Hologic, Inc. | 15 |
| Gold Marker | Riverpoint Medical LLC | 15 |
| MammoStar™ | Carbon Medical Technologies, Inc. | 15 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253761 | 2026-01-23 |
| K240527 | 2024-07-10 |
| K232615 | 2024-01-12 |
| K221961 | 2023-07-13 |
| K212158 | 2022-04-21 |
| K210752 | 2021-04-14 |
| K203097 | 2020-12-16 |
| K170803 | 2017-06-15 |
| K161021 | 2016-05-05 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Devicor Medical Products, Inc. | UDI-DI | 2022-03-30 | Class II | Labeling Change Control | 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. | 90 devices | 2024-04-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-24 | Class II | Labeling mix-ups | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. | 1910 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.