| Device Type ID | 5733 |
| Device Name | Razor, Surgical |
| 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 | LWK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5733 |
| Device | Razor, Surgical |
| Product Code | LWK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Overheating Of Device | 4 |
Temperature Problem | 2 |
Sharp/jagged/rough/etched/scratched | 2 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Device Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 13 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Jan-30-2019 |
| 2 | 3M Company - Health Care Business | II | Feb-28-2018 |
| 3 | Medline Industries Inc | II | Aug-20-2015 |