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 | ||
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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 |