| Device Type ID | 5493 |
| Device Name | Needle, Biopsy, Cardiovascular |
| 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 | DWO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5493 |
| Device | Needle, Biopsy, Cardiovascular |
| Product Code | DWO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 6 |
Fracture | 6 |
Tip | 4 |
Material Separation | 4 |
Component(s), Broken | 2 |
Needle | 2 |
Detachment Of Device Or Device Component | 1 |
Component Incompatible | 1 |
Material Fragmentation | 1 |
Failure To Obtain Sample | 1 |
Melted | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Bent | 1 |
| Total Device Problems | 31 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiotech (Manan Medical Products, Inc.) | II | Feb-07-2019 |
| 2 | Mermaid Medical A/S | II | Jul-22-2015 |