Definition: To Temporarily (< 30 Days) Mark A Tissue Site Intended For Surgical Removal. The Tissue Marker Is Surgically Removed With The Target Tissue.
| Device Type ID | 5858 |
| Device Name | Temporary Tissue Marker |
| Physical State | May Include: Implantable Marker, Delivery Device |
| Technical Method | Marks A Tissue Location By Being Visible Using Imaging Techniques. |
| Target Area | Tissue Intended To Be Removed Surgically |
| Regulation Description | Implantable Clip. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5858 |
| Device | Temporary Tissue Marker |
| Product Code | PBY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Implantable Clip. |
| CFR Regulation Number | 878.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENDOMAGNETICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALTH BEACONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |