# K241952: AQUABEAM Robotic System (AB2000)

- Pathway: 510(k) (Special)
- Applicant: Procept Biorobotics
- Decided: Sep 30, 2024 after 89 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: 4 generations back to DEN170024 (2017). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231024: AquaBeam Robotic System, Procept Biorobotics, Corporation (2023) Summary page 5.

## Most influential descendants
- K253211: AQUABEAM Robotic System (2026), 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/K241952
Methodology: https://510kreport.com/methodology