K241952 is an FDA 510(k) clearance for the AQUABEAM Robotic System (AB2000). This device is classified as a Fluid Jet Removal System (Class II - Special Controls, product code PZP).
Submitted by Procept Biorobotics (San Jose, US). The FDA issued a Cleared decision on September 30, 2024, 89 days after receiving the submission on July 3, 2024.
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 | K241952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2024 |
| Decision Date | September 30, 2024 |
| Days to Decision | 89 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |