Cleared Traditional

K260723 - HYDROS Robotic System (HY1000)

Also marketed or referenced as:
HYDROS Handpiece (HH1000) HYDROS TRUS Probe (HU1000)

K260723 is an FDA 510(k) clearance for HYDROS Robotic System (HY1000), manufactured by Procept Biorobotics. The device is a Class 2 Gastroenterology & Urology device with product code PZP cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K260723 · Procept Biorobotics · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
126d
Days
Class 2
Risk

K260723 is an FDA 510(k) clearance for the HYDROS Robotic System (HY1000). 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 July 9, 2026 after a review of 126 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 devices

FDA 510(k) Submission Details - K260723

510(k) Number K260723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2026
Decision Date July 09, 2026
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 130d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PZP Device Classification - Class 2, Special Controls

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 K260723.
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
AquaBeam Robotic System
K202961 · Procept Biorobotics, Corporation · Mar 2021