Not Cleared Direct

DEN170024 - AQUABEAM System (FDA 510(k) Clearance)

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

DEN170024 · Procept Biorobotics, Corporation · Gastroenterology & Urology device
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Dec 2017
Decision
248d
Days
Class 2
Risk

DEN170024 is an FDA 510(k) submission (not cleared) for the AQUABEAM 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 Not Cleared (DENG) decision on December 21, 2017 after a review of 248 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Procept Biorobotics, Corporation devices

Submission Details

510(k) Number DEN170024 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 17, 2017
Decision Date December 21, 2017
Days to Decision 248 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 130d · This submission: 248d
Pathway characteristics

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.

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