| Device Type ID | 5638 |
| Device Name | Scalpel, One-piece |
| 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 | GDX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5638 |
| Device | Scalpel, One-piece |
| Product Code | GDX |
| 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 | 3 |
Pitted | 3 |
Product Quality Problem | 2 |
Break | 2 |
Material Erosion | 1 |
Mechanical Jam | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Tip | 1 |
| Total Device Problems | 14 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Southmedic, Inc. | II | May-17-2018 |
| 2 | Zien Medical Technologies, Inc | II | Sep-21-2015 |