Definition: Controlled Compression Of A Piston Syringe
| Device Type ID | 2790 |
| Device Name | Piston Syringe Lever |
| Physical State | Syringe Holder With Proximal Advancement Mechanism Which Places Pressure Through Means Of A Screw Lever And Manual Proximal Screw-down Control Wheel |
| Technical Method | Precision Compression To Proximal End Of A Syringe Through Means Of A Lever. |
| Target Area | Urology |
| Regulation Description | Piston Syringe. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2790 |
| Device | Piston Syringe Lever |
| Product Code | QBL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Piston Syringe. |
| CFR Regulation Number | 880.5860 [🔎] |