Class Class II

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200)

K240200 2024-08-20 Traditional
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Description

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece by Procept Biorobotics, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK240200
Clearance Date2024-08-20
Clearance TypeTraditional
Product CodePZP
Regulation Number876.4350

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Predicate lineage for K240200

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece (K240200) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K231024AquaBeam Robotic SystemProcept Biorobotics, Corporation2023

Trace the full predicate network for K240200

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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