510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240200Substantially Equivalent

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

PROCEPT BioRobotics Corporation, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240200 is the FDA 510(k) clearance record for HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece, a class II device, cleared for Procept Biorobotics on under FDA product code PZP (Fluid Jet Removal System). FDA's definition for product code PZP reads: "The system is used for removal of prostate tissue with a fluid jet". FDA records list 9 510(k) clearances for Procept Biorobotics, from to . As of , FDA records show no recalls naming K240200.

Clearance record

Decision date
Received
(208 days to decision)
Product code
PZP Fluid Jet Removal System
Regulation
21 CFR 876.4350
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Procept Biorobotics 150 Baytech Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZP

Trailing 12 months
2 clearances under product code PZP in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260