# K202961: AquaBeam Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: Procept Biorobotics, Corporation
- Decided: Mar 11, 2021 after 162 days
- Product code: PZP (Fluid Jet Removal System)
- Device class: 2
- Regulation: 21 CFR 876.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN170024 (2017). 1 ancestor in all.
7 later devices descend from it; 1 cites 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.

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

## Recalls of this device
- Jul 9, 2021 · Class II · Z-2330-2021: Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the h

## 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/K202961
Methodology: https://510kreport.com/methodology