| Device Type ID | 5587 |
| Device Name | Snare, Surgical |
| 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 | GAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5587 |
| Device | Snare, Surgical |
| Product Code | GAE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 11 |
Material Separation | 10 |
Break | 4 |
Deformation Due To Compressive Stress | 3 |
Bent | 2 |
Detachment Of Device Component | 2 |
Filter | 1 |
Difficult To Advance | 1 |
Positioning Problem | 1 |
Device Operates Differently Than Expected | 1 |
Failure To Adhere Or Bond | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Tip | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 41 |