# K231024: AquaBeam Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: Procept Biorobotics, Corporation
- Decided: Aug 30, 2023 after 141 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
Longest line of descent: 3 generations back to DEN170024 (2017). 3 ancestors in all.
5 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)
- DEN170024: AQUABEAM System, Procept Biorobotics, Corporation (2017) Summary page 4.
- K212835: AquaBeam Robotic System, Procept Biorobotics, Corporation (2021) Summary page 4.

## Most influential descendants
- 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
- K260723: HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (2026), 0 descendants of its own
- K253211: AQUABEAM Robotic System (2026), 0 descendants of its own
- K251082: HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) (2025), 0 descendants of its own

## Indications for use
The AQUABEAM Robotic 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/K231024
Methodology: https://510kreport.com/methodology