NEU — Marker, Radiographic, Implantable Class II
FDA product code NEU covers "Marker, Radiographic, Implantable", a Class II medical device regulated under 21 CFR 878.4300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |