| Device Type ID | 5629 |
| Device Name | Dissector, 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 | GDI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5629 |
| Device | Dissector, Surgical, General & Plastic Surgery |
| Product Code | GDI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 9 |
Break | 8 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Fracture | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Material Separation | 1 |
| Total Device Problems | 26 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |