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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 / May 2026 / K260183

510(k) cleared

MediBot Needle Driver Uno

Parallel Robotics, LLC · May 24, 2026 · K260183

FDA cleared the MediBot Needle Driver Uno from Parallel Robotics, LLC on May 24, 2026 under K260183, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 21, 2026. The decision came 123 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Parallel Robotics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260183?

K260183 is the FDA 510(k) for MediBot Needle Driver Uno, submitted by Parallel Robotics, LLC. FDA's decision date was May 24, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the MediBot Needle Driver Uno?

Parallel Robotics, LLC, based in Ann Arbor, MI, is the applicant of record for K260183.

How long did the K260183 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on May 24, 2026, 123 days later.

← All decisions in May 2026