WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / July 2026 / K260723

510(k) cleared

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

Procept Biorobotics · Jul 9, 2026 · K260723

FDA cleared the HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) from Procept Biorobotics on Jul 9, 2026 under K260723, 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 Mar 5, 2026. The decision came 126 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: K253211 (AQUABEAM Robotic System), K251082 (HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)).

Questions & Answers

What did FDA clear under K260723?

K260723 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 Jul 9, 2026, 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 K260723.

How long did the K260723 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on Jul 9, 2026, 126 days later.

← All decisions in July 2026

Sources