DEN170024 is an FDA 510(k) submission for the AQUABEAM System. This device is classified as a Fluid Jet Removal System (Class II - Special Controls, product code PZP).
Submitted by Procept Biorobotics, Corporation (Redwood City, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4350. The System Is Used For Removal Of Prostate Tissue With A Fluid Jet..
| 510(k) Number | DEN170024 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | April 17, 2017 |
| Decision Date | December 21, 2017 |
| Days to Decision | 248 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | PZP - Fluid Jet Removal System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4350 |
| Definition | The System Is Used For Removal Of Prostate Tissue With A Fluid Jet. |