K-number	K240200
Device name	HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece
Applicant	Procept Biorobotics
Product code	PZP
Device class	Class II
Decision date	Aug 20, 2024
Decision	Substantially Equivalent
Regulation	876.4350

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Source

View the full FDA submission: accessdata.fda.gov

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HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

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