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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K251082

510(k) cleared

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

Procept Biorobotics · Oct 10, 2025 · K251082

FDA cleared the HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000) from Procept Biorobotics on Oct 10, 2025 under K251082, a traditional 510(k). The device falls under product code PZP, Fluid Jet Removal System, regulated at 21 CFR 876.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 9, 2025. The decision came 184 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Procept Biorobotics has 2 other decisions in the tracker over the last 12 months: K260723 (HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000)), K253211 (AQUABEAM Robotic System).

Questions & Answers

What did FDA clear under K251082?

K251082 is the FDA 510(k) for HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000), submitted by Procept Biorobotics. FDA's decision date was Oct 10, 2025, under product code PZP (Fluid Jet Removal System).

Who makes the HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)?

Procept Biorobotics, based in San Jose, CA, is the applicant of record for K251082.

How long did the K251082 review take?

FDA received the submission on Apr 9, 2025 and issued its decision on Oct 10, 2025, 184 days later.

← All decisions in October 2025

Sources