NEU
- Product code
- NEU
- Device name
- Marker, Radiographic, Implantable
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4300
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 15 (direct download)
- 510(k) clearances (all years, FDA)
- 110 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253761 | 2026-01-23 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly… | FDA |
| K253888 | 2025-12-31 | Stryker Endoscopy | MOLLI 2 System | |
| K252892 | 2025-12-19 | Merit Medical Systems, Inc. | SCOUT MD Surgical Guidance System | |
| K251989 | 2025-12-12 | Breast-Med, Inc. | VizMark Preloaded Tissue Marker Device (VM-0001) | |
| K251748 | 2025-07-23 | Carbon Medical Technologies, Inc. | MammoSTAR Biopsy Site Identifier | |
| K243642 | 2025-03-24 | Bard Peripheral Vascular, Inc. | UltraCor Twirl Breast Tissue Marker | |
| K233639 | 2024-12-20 | Elucent Medical, Inc. | SmartClip Secure Soft Tissue Marker | |
| K240429 | 2024-11-07 | Inrad, Inc. | Trilogy Tissue Marker | |
| K234149 | 2024-09-26 | Molli Surgical, Inc. | MOLLI 2 System | |
| K240042 | 2024-09-25 | Molli Surgical, Inc. | MOLLI 2 System | |
| K241762 | 2024-09-16 | View Point Medical | OneMark | |
| K240527 | 2024-07-10 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker (Hummingbi… | FDA |
| K232865 | 2024-06-28 | Endomagnetics Ltd., | Magseed Pro Magnetic Marker System | |
| K231468 | 2024-02-12 | Merit Medical System, Inc. | SCOUT MD Surgical Guidance System | |
| K230836 | 2024-01-23 | Surgmark GmbH | SchurSign Tissue Marker | |
| K232615 | 2024-01-12 | Devicor Medical Products, Inc. | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape))… | |
| K231579 | 2023-10-26 | Molli Surgical, Inc. | MOLLI 2 |
Official FDA classification page: NEU
Classification and pathway per current FDA publications. Data from openFDA (CC0).