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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 / K261410

510(k) cleared

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

Suite 201, National Innovation Centre · Jul 30, 2026 · K261410

FDA cleared the Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) from Suite 201, National Innovation Centre on Jul 30, 2026 under K261410, 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 Apr 30, 2026. The decision came 91 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 Suite 201, National Innovation Centre in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261410?

K261410 is the FDA 510(k) for Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)), submitted by Suite 201, National Innovation Centre. FDA's decision date was Jul 30, 2026, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))?

Suite 201, National Innovation Centre, based in Nsw, is the applicant of record for K261410.

How long did the K261410 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Jul 30, 2026, 91 days later.

← All decisions in July 2026