Cleared Traditional

K202961 - AquaBeam Robotic System (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202961 · Procept Biorobotics, Corporation · Gastroenterology & Urology device
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Mar 2021
Decision
162d
Days
Class 2
Risk

K202961 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 March 11, 2021 after a review of 162 days - an extended review cycle.

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

Submission Details

510(k) Number K202961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date March 11, 2021
Days to Decision 162 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 130d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K202961.
HYDROS Robotic System (HY1000)
K251082 · Procept Biorobotics · Oct 2025
AQUABEAM Robotic System (AB2000)
K241952 · Procept Biorobotics · Sep 2024
HYDROS Robotic System
K240200 · Procept Biorobotics · Aug 2024
AquaBeam Robotic System
K231024 · Procept Biorobotics, Corporation · Aug 2023
AquaBeam Robotic System
K212835 · Procept Biorobotics, Corporation · Oct 2021