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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 / December 2025 / K253661

510(k) cleared

TMINI Miniature Robotic System

THINK Surgical, Inc. · Dec 22, 2025 · K253661

FDA cleared the TMINI Miniature Robotic System from THINK Surgical, Inc. on Dec 22, 2025 under K253661, a special 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 Nov 20, 2025. The decision came 32 days later, inside the 90 FDA-day goal for a 510(k).

THINK Surgical, Inc. has 3 other decisions in the tracker over the last 12 months: K261024 (TMINI Miniature Robotic System), K260010 (TMINI® Miniature Robotic System), K252544 (TMINI Miniature Robotic System).

Questions & Answers

What did FDA clear under K253661?

K253661 is the FDA 510(k) for TMINI Miniature Robotic System, submitted by THINK Surgical, Inc.. FDA's decision date was Dec 22, 2025, 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 K253661.

How long did the K253661 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Dec 22, 2025, 32 days later.

← All decisions in December 2025

Sources