Product code NEU
- Device name
- Marker, Radiographic, Implantable
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4300
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | 2026-01-23 |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 2025-12-31 |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | 2025-12-19 |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | 2025-12-12 |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | 2025-07-23 |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025-03-24 |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024-12-20 |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | 2024-11-07 |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-26 |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-25 |
| K241762 | OneMark | View Point Medical | 2024-09-16 |
| K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | 2024-07-10 |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | 2024-06-28 |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024-02-12 |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | 2024-01-23 |
| K232615 | LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) | Devicor Medical Products, Inc. | 2024-01-12 |
| K231579 | MOLLI 2 | Molli Surgical, Inc. | 2023-10-26 |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2023-07-13 |
| K222832 | Sentimag System | Endomagnetics Ltd., | 2023-01-21 |
| K223107 | MOLLI 2 | Molli Surgical, Inc. | 2023-01-18 |
| K212158 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2022-04-21 |
| K212882 | SCOUT BX Delivery System | Merit Medical Systems, Inc. | 2022-04-08 |
| K210600 | MOLLI | Molli Surgical, Inc. | 2021-04-16 |
| K210752 | HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 2021-04-14 |
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | Somatex Medical Technologies GmbH | 2021-02-18 |
| K203097 | HydroMARK Breast Biopsy Site Markers | Devicor Medical Products, Inc. | 2020-12-16 |
| K192771 | C4 Fiducial Marker | C4 Imaging, LLC | 2020-10-21 |
| K193189 | RFID Localization System | Health Beacons, Inc. | 2020-05-06 |
| K183503 | EasyMark Tissue Marker | Inrad, Inc. | 2019-10-17 |
| K192371 | BioZorb SP Marker | Focal Therapeutics | 2019-09-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884450392867 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392874 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392881 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392935 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392942 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392959 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392966 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 00884450392850 | SCOUT MD™ | Merit Medical Systems, Inc. | 2026-05-28 |
| 08719992742592 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 08719992742998 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 08719992742974 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 08719992742943 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 08719992742882 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 08719992742530 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 08719992742516 | Sirius Pintuition | Sirius Medical Systems B.V. | 2024-11-22 |
| 10851674008291 | SmartClip | Elucent Medical, Inc. | 2022-11-04 |
| 10851674008284 | SmartClip | Elucent Medical, Inc. | 2022-11-04 |
| 10851674008277 | SmartClip | Elucent Medical, Inc. | 2022-11-04 |
| 10851674008260 | SmartClip | Elucent Medical, Inc. | 2022-11-04 |
| 10851674008253 | SmartClip | Elucent Medical, Inc. | 2022-11-04 |
| 10851674008093 | SmartClip | Elucent Medical, Inc. | 2022-11-04 |
| 10851674008178 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008185 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008192 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008208 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008215 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008161 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008154 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008147 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |
| 10851674008130 | SmartClip | Elucent Medical, Inc. | 2020-04-13 |