Device Type ID | 5591 |
Device Name | Stripper, Vein, Reusable |
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 | GAI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5591 |
Device | Stripper, Vein, Reusable |
Product Code | GAI |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Surgical Instrument For General Use. |
CFR Regulation Number | 878.4800 [🔎] |
Device Problems | |
---|---|
Fracture | 5 |
Break | 4 |
Detachment Of Device Or Device Component | 1 |
Total Device Problems | 10 |