FDA cleared the ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) from Medtronic Xomed, Inc. on Sep 4, 2026 under K262235, 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 Jul 1, 2026. The decision came 65 days later, inside the 90 FDA-day goal for a 510(k).
Medtronic Xomed, Inc. has one other decision in the tracker over the last 12 months: K251672 (NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)).
Questions & Answers
What did FDA clear under K262235?
K262235 is the FDA 510(k) for ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM), submitted by Medtronic Xomed, Inc.. FDA's decision date was Sep 4, 2026, under product code PGW (Ear, Nose, And Throat Stereotaxic Instrument).
Who makes the ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM)?
Medtronic Xomed, Inc., based in Jacksonville, FL, is the applicant of record for K262235.
How long did the K262235 review take?
FDA received the submission on Jul 1, 2026 and issued its decision on Sep 4, 2026, 65 days later.