NEU · Marker, Radiographic, Implantable
General, Plastic Surgery · 21 CFR 878.4300 · Class 2
Overview
| Product Code | NEU |
|---|---|
| Device Name | Marker, Radiographic, Implantable |
| Regulation | 21 CFR 878.4300 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| Implant | Yes |
Identification
An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 110)
Showing 20 most recent of 110 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | Jan 23, 2026 | SESE |
| K253888 | MOLLI 2 System | Stryker Endoscopy | Dec 31, 2025 | SESE |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | Dec 19, 2025 | SESE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | Dec 12, 2025 | SESE |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | Jul 23, 2025 | SESE |
| K243642 | UltraCor Twirl Breast Tissue Marker | Bard Peripheral Vascular, Inc. | Mar 24, 2025 | SESE |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | Dec 20, 2024 | SESE |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | Nov 7, 2024 | SESE |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | Sep 26, 2024 | SESE |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | Sep 25, 2024 | SESE |
| K241762 | OneMark | View Point Medical | Sep 16, 2024 | SESE |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | Jul 10, 2024 | SESE |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | Jun 28, 2024 | SESE |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | Feb 12, 2024 | SESE |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | Jan 23, 2024 | SESE |
| 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. | Jan 12, 2024 | SESE |
| K231579 | MOLLI 2 | Molli Surgical, Inc. | Oct 26, 2023 | SESE |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Devicor Medical Products, Inc. | Jul 13, 2023 | SESE |
| K222832 | Sentimag System | Endomagnetics Ltd., | Jan 21, 2023 | SESE |
| K223107 | MOLLI 2 | Molli Surgical, Inc. | Jan 18, 2023 | SESE |
Top Applicants
- Devicor Medical Products, Inc. — 9 clearances
- Senorx, Inc. — 7 clearances
- Somatex Medical Technologies GmbH — 6 clearances
- Carbon Medical Technologies, Inc. — 6 clearances
- Biopsy Sciences, LLC — 6 clearances
