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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 / K262121

510(k) cleared

Ion-L Navigated Instruments

SurGenTec, LLC · Jul 24, 2026 · K262121

FDA cleared the Ion-L Navigated Instruments from SurGenTec, LLC on Jul 24, 2026 under K262121, 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 Jun 23, 2026. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

SurGenTec, LLC has 4 other decisions in the tracker over the last 12 months: K261209 (Ion-L), K260329 (Ion-C Navigation Instruments), K253604 (TiLink-L Navigation Instruments), K251714 (Ion-C).

Questions & Answers

What did FDA clear under K262121?

K262121 is the FDA 510(k) for Ion-L Navigated Instruments, submitted by SurGenTec, LLC. FDA's decision date was Jul 24, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Ion-L Navigated Instruments?

SurGenTec, LLC, based in Boca Raton, FL, is the applicant of record for K262121.

How long did the K262121 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Jul 24, 2026, 31 days later.

← All decisions in July 2026

Sources