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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 / March 2026 / K252926

510(k) cleared

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)

Restore Robotics · Mar 26, 2026 · K252926

FDA cleared the Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) from Restore Robotics on Mar 26, 2026 under K252926, a traditional 510(k). The device falls under product code QSM, System, Surgical, Computer Controlled Instrument, Remanufactured, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 15, 2025. The decision came 192 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 Restore Robotics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252926?

K252926 is the FDA 510(k) for Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184), submitted by Restore Robotics. FDA's decision date was Mar 26, 2026, under product code QSM (System, Surgical, Computer Controlled Instrument, Remanufactured).

Who makes the Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)?

Restore Robotics, based in Henderson, NV, is the applicant of record for K252926.

How long did the K252926 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Mar 26, 2026, 192 days later.

← All decisions in March 2026