| Device Type ID | 5628 |
| Device Name | Gouge, 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 Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GDH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5628 |
| Device | Gouge, Surgical, General & Plastic Surgery |
| Product Code | GDH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 10 |
Detachment Of Device Component | 9 |
Difficult To Insert | 5 |
Crack | 2 |
Detachment Of Device Or Device Component | 2 |
Packaging Problem | 2 |
Device Packaging Compromised | 2 |
Obturator | 2 |
Material Fragmentation | 1 |
Split | 1 |
Flaked | 1 |
| Total Device Problems | 37 |