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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 / July 2026 / K261024

510(k) cleared

TMINI Miniature Robotic System

THINK Surgical, Inc. · Jul 24, 2026 · K261024

FDA cleared the TMINI Miniature Robotic System from THINK Surgical, Inc. on Jul 24, 2026 under K261024, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 30, 2026. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

THINK Surgical, Inc. has 3 other decisions in the tracker over the last 12 months: K260010 (TMINI® Miniature Robotic System), K253661 (TMINI Miniature Robotic System), K252544 (TMINI Miniature Robotic System).

Questions & Answers

What did FDA clear under K261024?

K261024 is the FDA 510(k) for TMINI Miniature Robotic System, submitted by THINK Surgical, Inc.. FDA's decision date was Jul 24, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the TMINI Miniature Robotic System?

THINK Surgical, Inc., based in Fremont, CA, is the applicant of record for K261024.

How long did the K261024 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Jul 24, 2026, 116 days later.

← All decisions in July 2026

Sources