# DEN170024: AQUABEAM System

- Pathway: De Novo (Direct)
- Applicant: Procept Biorobotics, Corporation
- Decided: Dec 21, 2017 after 248 days
- Product code: PZP (Fluid Jet Removal System)
- Device class: 2
- Regulation: 21 CFR 876.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K202961: AquaBeam Robotic System (2021), 7 descendants of its own
- K212835: AquaBeam Robotic System (2021), 6 descendants of its own
- K231024: AquaBeam Robotic System (2023), 5 descendants of its own
- K240200: HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (2024), 2 descendants of its own
- K241952: AQUABEAM Robotic System (AB2000) (2024), 1 descendant of its own

## Indications for use
The AQUABEAM System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.

Source page: https://510kreport.com/device/DEN170024
Methodology: https://510kreport.com/methodology