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PZP — Fluid Jet Removal System Class II

FDA Device Classification

Classification Details

Product Code
PZP
Device Class
Class II
Regulation Number
876.4350
Submission Type
Review Panel
GU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

The system is used for removal of prostate tissue with a fluid jet.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251082procept bioroboticsHYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HUOctober 10, 2025
K241952procept bioroboticsAQUABEAM Robotic System (AB2000)September 30, 2024
K240200procept bioroboticsHYDROS Robotic System; HYDROS TRUS Probe; HYDROS HandpieceAugust 20, 2024
K231024procept biorobotics, corporationAquaBeam Robotic SystemAugust 30, 2023
K212835procept biorobotics, corporationAquaBeam Robotic SystemOctober 6, 2021
K202961procept biorobotics, corporationAquaBeam Robotic SystemMarch 11, 2021
DEN170024procept biorobotics, corporationAQUABEAM SystemDecember 21, 2017