| Device Type ID | 5745 |
| Device Name | Needle, Tumor Localization |
| Regulation Description | Manual Surgical Instrument For General Use. |
| 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) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MIJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5745 |
| Device | Needle, Tumor Localization |
| Product Code | MIJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 5 |
Break | 4 |
Fracture | 4 |
Migration Or Expulsion Of Device | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Melted | 1 |
Detachment Of Device Or Device Component | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 22 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Feb-29-2016 |