HydroMARK
The FDA filing describes HydroMARK as a two-component breast biopsy site marker with a resorbable hydrogel and metallic component. It provides permanent marking of a breast biopsy site. It…
The FDA filing describes HydroMARK as a two-component breast biopsy site marker with a resorbable hydrogel and metallic component. It provides permanent marking of a breast biopsy site.
It is intended to mark tissue during percutaneous breast biopsy. The filing says the marker is visible under ultrasound for at least six weeks and permanently visible by X-ray and MRI.
Listed Item
HydroMARK Breast Biopsy Site Marker SHORT – CE
Removal Limit
The subject device is not intended to be removed unless the marked tissue is determined to require surgical removal.
1manufacturer
75catalogue 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 | 2025-10-15 |
| Record revised | 2026-06-19 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| 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 8 to 18 G |
| Distribution end date | 2025-09-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4010-03-09-T1 | In distribution | |
| CA000410003 | Needle Gauge 8 G | In distribution |
| 4010-02-15-T4 | In distribution | |
| 4010-02-18-T3 | In distribution | |
| 4010-03-15-T3 | In distribution | |
| CA000411003 | Needle Gauge 11 G | In distribution |
| CA000515004 | In distribution | |
| 4010-01-11-T3 | In distribution | |
| 4010-03-09-T3 | In distribution | |
| 4010-02-15-T1 | In distribution | |
| CA000413002 | In distribution | |
| 4010-04-09-T4 | In distribution | |
| CA000520004 | In distribution | |
| CA000412001 | In distribution | |
| CA000515005 | In distribution | |
| CA000408002 | Needle Gauge 9 G | In distribution |
| CA000995002 | In distribution | |
| 4010-04-09-T1 | In distribution | |
| CA000407005 | In distribution | |
| CA000520006 | In distribution | |
| CA000408004 | Needle Gauge 9 G | In distribution |
| 4010-05-10-T4 | In distribution | |
| CA000412002 | In distribution | |
| CA000408001 | Needle Gauge 9 G | In distribution |
| 4010-05-10-T3 | In distribution | |
| 4010-01-08-T1 | In distribution | |
| 4010-05-10-T1 | In distribution | |
| CA000411001 | Needle Gauge 11 G | In distribution |
| 4010-02-15-T3 | In distribution | |
| CA000410004 | Needle Gauge 8 G | In distribution |
| CA000407002 | In distribution | |
| 4010-02-15-S1 | In distribution | |
| CA000408003 | Needle Gauge 9 G | In distribution |
| 4010-05-08-T4 | In distribution | |
| CA000407001 | In distribution | |
| CA000407003 | In distribution | |
| 4010-04-09-S3 | In distribution | |
| CA000413001 | In distribution | |
| CA000520005 | In distribution | |
| 4010-03-15-T1 | In distribution | |
| CA000407004 | In distribution | |
| 4010-01-11-T4 | In distribution | |
| CA000411002 | Needle Gauge 11 G | In distribution |
| CA000410001 | Needle Gauge 8 G | In distribution |
| 4010-05-08-T1 | In distribution | |
| 4010-01-08-T4 | In distribution | |
| CA000409001 | In distribution | |
| CA000515006 | In distribution | |
| 4010-02-15-S3 | In distribution | |
| 4010-01-08-T3 | In distribution | |
| 4010-01-08-S1 | In distribution | |
| 4010-01-11-T1 | In distribution | |
| CA000410002 | Needle Gauge 8 G | In distribution |
| 4010-04-09-T3 | In distribution | |
| 4010-02-15-S1 | Needle Gauge 15 G | Withdrawn |
| 4010-03-09-T1 | Needle Gauge 9 G | Withdrawn |
| 4010-03-15-T1-SHORT | Needle Gauge 15 G | Withdrawn |
| 4010-04-09-T1 | Needle Gauge 9 G | Withdrawn |
| 4010-01-08-T4 | Needle Gauge 8 G | Withdrawn |
| 4010-03-15-T3-SHORT | Needle Gauge 15 G | Withdrawn |
| 4010-02-15-T4 | Needle Gauge 15 G | Withdrawn |
| 4010-04-09-T3 | Needle Gauge 9 G | Withdrawn |
| 4010-02-15-S3 | Needle Gauge 15 G | Withdrawn |
| 4010-01-08-T3 | Needle Gauge 8 G | Withdrawn |
| 4010-01-11-T1 | Needle Gauge 11 G | Withdrawn |
| 4010-02-15-T1 | Needle Gauge 15 G | Withdrawn |
| 4010-01-08-T1 | Needle Gauge 8 G | Withdrawn |
| 4010-04-09-S3 | Needle Gauge 9 G | Withdrawn |
| 4010-03-09-T3 | Needle Gauge 9 G | Withdrawn |
| 4010-01-11-T3 | Needle Gauge 11 G | Withdrawn |
| 4010-01-11-T4 | Needle Gauge 11 G | Withdrawn |
| 4010-02-15-T3 | Needle Gauge 15 G | Withdrawn |
| 4010-01-08-S1 | Needle Gauge 8 G | Withdrawn |
| 4010-04-09-T4 | Needle Gauge 9 G | Withdrawn |
| 4010-02-18-T3 | Needle Gauge 18 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Mammotome revolve MammoMark | Devicor Medical Products, Inc. | 10 |
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 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Devicor Medical Products, Inc. | 510(k) number | 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 |
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 | Closed |
|---|---|---|---|---|---|
| 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 |
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.