| Device Type ID | 5640 |
| Device Name | Handle, Scalpel |
| 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 | GDZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5640 |
| Device | Handle, Scalpel |
| Product Code | GDZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 7 |
Retraction Problem | 7 |
Break | 6 |
Material Protrusion / Extrusion | 4 |
Material Integrity Problem | 4 |
Use Of Device Problem | 2 |
Misassembled | 2 |
Protective Measures Problem | 2 |
Device Handling Problem | 2 |
Device Misassembled During Manufacturing / Shipping | 2 |
Overheating Of Device | 2 |
Premature Activation | 1 |
Insufficient Information | 1 |
Device-Device Incompatibility | 1 |
Activation, Positioning Or Separation Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ansell Sandel Medical Industries LLC | II | Jan-08-2014 |
| 2 | Bard Access Systems | II | Apr-14-2015 |
| 3 | Integra York PA, Inc | II | May-31-2016 |
| 4 | Teleflex Medical | II | Oct-16-2017 |