K231024 is an FDA 510(k) clearance for the AquaBeam Robotic System. Classified as Fluid Jet Removal System (product code PZP), Class II - Special Controls.
Submitted by Procept Biorobotics, Corporation (Redwood City, US). The FDA issued a Cleared decision on August 30, 2023 after a review of 141 days - within the typical 510(k) review window.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4350 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Procept Biorobotics, Corporation devices
NCT02505919
Completed
Interventional
Industry-sponsored
Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)
A Prospective Multicenter Randomized Blinded Study Comparing Aquablation of the Prostate With the AQUABEAM System and TURP for the Treatment of LUTS
| Condition studied |
Benign Prostatic Hyperplasia (BPH) |
| Study design |
Parallel |
| Eligibility |
Male only
· 45 Years+
|
| Principal investigator |
Peter Gilling, M.D. |
| Sponsor |
PROCEPT BioRobotics
(industry)
|
Started 2015-10-30
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Primary completion 2017-07-14
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Completed 2021-12-16
Primary outcome
Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)
View full study on ClinicalTrials.gov