Definition: Locating Lymph Nodes Draining A Tumor As Part Of The Sentinel Lymph Node Biopsy Procedure
| Device Type ID | 5964 |
| Device Name | Lymph Node Location System During Sentinel Biopsy Procedure |
| Physical State | The Solution Is Considered A Combination Product. The Iron Particle Is Surrounded By A Carboxydextran Coating. The Carboxydextran Coating Is Considered A Drug. The Nanoparticles Are Then Mixed In A Saline Solution. The System Uses An Electronic Base |
| Technical Method | The Solution Is Composed Of Iron Nanoparticles Which Is Injected Peri-tumor. The Nanoparticles Are Taken Up By The Lymphatic System And Remains There. The Magnetic Probe Is Used To Locate The Iron Nanoparticles Which Should Collect In The Lymph Nodes |
| Target Area | Cancer Tumor |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PUV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5964 |
| Device | Lymph Node Location System During Sentinel Biopsy Procedure |
| Product Code | PUV |
| FDA Device Classification | Class 3 Medical Device |