| Device Type ID | 5627 |
| Device Name | Hook, Surgical, General & Plastic Surgery |
| 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 One - Light Based/Laser (GSDB1) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5627 |
| Device | Hook, Surgical, General & Plastic Surgery |
| Product Code | GDG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 43 |
Degraded | 4 |
Material Disintegration | 3 |
Fracture | 3 |
Detachment Of Device Or Device Component | 2 |
Insufficient Information | 2 |
Material Fragmentation | 2 |
Missing Value Reason | 1 |
Device Operates Differently Than Expected | 1 |
Material Discolored | 1 |
Appropriate Term/Code Not Available | 1 |
No Audible Alarm | 1 |
| Total Device Problems | 64 |