NEU — Marker, Radiographic, Implantable Class II
FDA Device Classification
Classification Details
- Product Code
- NEU
- Device Class
- Class II
- Regulation Number
- 878.4300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253761 | devicor medical products | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Bre | January 23, 2026 |
| K253888 | stryker endoscopy | MOLLI 2 System | December 31, 2025 |
| K252892 | merit medical systems | SCOUT MD Surgical Guidance System | December 19, 2025 |
| K251989 | breast-med | VizMark Preloaded Tissue Marker Device (VM-0001) | December 12, 2025 |
| K251748 | carbon medical technologies | MammoSTAR Biopsy Site Identifier | July 23, 2025 |
| K243642 | bard peripheral vascular | UltraCor Twirl Breast Tissue Marker | March 24, 2025 |
| K233639 | elucent medical | SmartClip Secure Soft Tissue Marker | December 20, 2024 |
| K240429 | inrad | Trilogy Tissue Marker | November 7, 2024 |
| K234149 | molli surgical | MOLLI 2 System | September 26, 2024 |
| K240042 | molli surgical | MOLLI 2 System | September 25, 2024 |
| K241762 | view point medical | OneMark | September 16, 2024 |
| K240527 | devicor medical products | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | July 10, 2024 |
| K232865 | endomagnetics ltd | Magseed Pro Magnetic Marker System | June 28, 2024 |
| K231468 | merit medical system | SCOUT MD Surgical Guidance System | February 12, 2024 |
| K230836 | surgmark | SchurSign Tissue Marker | January 23, 2024 |
| K232615 | devicor medical products | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Mark | January 12, 2024 |
| K231579 | molli surgical | MOLLI 2 | October 26, 2023 |
| K221961 | devicor medical products | HydroMARK Plus Breast Biopsy Site Marker | July 13, 2023 |
| K222832 | endomagnetics ltd | Sentimag System | January 21, 2023 |
| K223107 | molli surgical | MOLLI 2 | January 18, 2023 |