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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 / March 2026 / K253395

510(k) cleared

Stealth AXiS ENT clinical application

Medtronic Navigation, Inc. · Mar 16, 2026 · K253395

FDA cleared the Stealth AXiS ENT clinical application from Medtronic Navigation, Inc. on Mar 16, 2026 under K253395, a traditional 510(k). The device falls under product code PGW, Ear, Nose, And Throat 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 Sep 30, 2025. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Navigation, Inc. has 4 other decisions in the tracker over the last 12 months: K253379 (Stealth AXiS Cranial clinical application), K253391 (Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)), K253381 (Stealth AXiS Surgical System with Stealth AXiS Spine clinical application), K251282 (StealthStation S8 Spine Software).

Questions & Answers

What did FDA clear under K253395?

K253395 is the FDA 510(k) for Stealth AXiS ENT clinical application, submitted by Medtronic Navigation, Inc.. FDA's decision date was Mar 16, 2026, under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).

Who makes the Stealth AXiS ENT clinical application?

Medtronic Navigation, Inc., based in Lafayette, CO, is the applicant of record for K253395.

How long did the K253395 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Mar 16, 2026, 167 days later.

← All decisions in March 2026