K212835 is an FDA 510(k) clearance for the AquaBeam Robotic 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 Cleared decision on October 6, 2021, 29 days after receiving the submission on September 7, 2021.
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 | K212835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2021 |
| Decision Date | October 06, 2021 |
| Days to Decision | 29 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. |