Definition: The System Is Used For Removal Of Prostate Tissue With A Fluid Jet.
| Device Type ID | 2180 |
| Device Name | Fluid Jet Removal System |
| Physical State | The System Consists Of A Hand Piece Through Which The Fluid Exits, And May Have A Conformal Planning Unit (CPU), Which Is Used In Treatment Planning. |
| Technical Method | The System Is A Personalized Image-guided Tissue Removal System That Uses A High-velocity Fluid Jet To Resect And Remove A Predetermined Volume Of Tissue. |
| Target Area | Prostate. |
| Regulation Description | Fluid Jet System For Prostate Tissue Removal. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PZP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2180 |
| Device | Fluid Jet Removal System |
| Product Code | PZP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fluid Jet System For Prostate Tissue Removal. |
| CFR Regulation Number | 876.4350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PROCEPT BIOROBOTICS CORPORATION | ||
GRANTED | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 18 |
Use Of Device Problem | 3 |
No Apparent Adverse Event | 2 |
Pump | 2 |
| Total Device Problems | 25 |