Cleared Special

K241952 - AQUABEAM Robotic System (AB2000) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241952 · Procept Biorobotics · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
89d
Days
Class 2
Risk

K241952 is an FDA 510(k) clearance for the AQUABEAM Robotic System (AB2000). Classified as Fluid Jet Removal System (product code PZP), Class II - Special Controls.

Submitted by Procept Biorobotics (San Jose, US). The FDA issued a Cleared decision on September 30, 2024 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4350 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Procept Biorobotics devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 130d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PZP Fluid Jet Removal System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4350
Definition The System Is Used For Removal Of Prostate Tissue With A Fluid Jet.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - PZP Fluid Jet Removal System

Devices cleared under the same product code (PZP) and FDA review panel - the closest regulatory comparables to K241952.
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