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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 / June 2026 / K253211

510(k) cleared

AQUABEAM Robotic System

Procept Biorobotics · Jun 23, 2026 · K253211

FDA cleared the AQUABEAM Robotic System from Procept Biorobotics on Jun 23, 2026 under K253211, 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 Sep 29, 2025. The decision came 267 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)), K251082 (HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)).

Questions & Answers

What did FDA clear under K253211?

K253211 is the FDA 510(k) for AQUABEAM Robotic System, submitted by Procept Biorobotics. FDA's decision date was Jun 23, 2026, under product code PZP (Fluid Jet Removal System).

Who makes the AQUABEAM Robotic System?

Procept Biorobotics, based in San Jose, CA, is the applicant of record for K253211.

How long did the K253211 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 23, 2026, 267 days later.

← All decisions in June 2026

Sources