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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 / June 2026 / K260709

510(k) cleared

ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)

Longeviti Neuro Solutions · Jun 25, 2026 · K260709

FDA cleared the ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) from Longeviti Neuro Solutions on Jun 25, 2026 under K260709, a traditional 510(k). The device falls under product code GXN, Plate, Cranioplasty, Preformed, Non-Alterable, regulated at 21 CFR 882.5330 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Mar 4, 2026. The decision came 113 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 Longeviti Neuro Solutions in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260709?

K260709 is the FDA 510(k) for ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754), submitted by Longeviti Neuro Solutions. FDA's decision date was Jun 25, 2026, under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable).

Who makes the ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)?

Longeviti Neuro Solutions, based in Baltimore, MD, is the applicant of record for K260709.

How long did the K260709 review take?

FDA received the submission on Mar 4, 2026 and issued its decision on Jun 25, 2026, 113 days later.

← All decisions in June 2026