Definition: An Internal Tissue Marker Is A Prescription Use Device That Is Intended For Use Prior To Or During General Surgical Procedures To Demarcate Selected Sites On Internal Tissues.
| Device Type ID | 5860 |
| Device Name | Internal Tissue Marker |
| Physical State | Marker With Dye. |
| Technical Method | A Biocompatible Dye That Is Applied To The Target Tissue Using A Soft Tipped Marker. |
| Target Area | Organs, Veins, Arteries And Other Internal Tissues. |
| Regulation Description | Internal Tissue Marker. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 510(k) |
| CFR Regulation Number | 878.4670 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5860 |
| Device | Internal Tissue Marker |
| Product Code | PDW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Internal Tissue Marker. |
| CFR Regulation Number | 878.4670 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CIANNA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MOERAE MATRIX, INC. | ||
GRANTED | 1 | |