FDA cleared the MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF from Cerenovus, Inc. on Aug 14, 2026 under K262419, a special 510(k). The device falls under product code HCG, Device, Neurovascular Embolization, regulated at 21 CFR 882.5950 as a Class 2 device. The review panel was Neurology.
FDA logged the submission as received on Jul 15, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).
Cerenovus, Inc. has one other decision in the tracker over the last 12 months: K262398 (CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set).
Questions & Answers
What did FDA clear under K262419?
K262419 is the FDA 510(k) for MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF, submitted by Cerenovus, Inc.. FDA's decision date was Aug 14, 2026, under product code HCG (Device, Neurovascular Embolization).
Who makes the MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF?
Cerenovus, Inc., based in Irvine, CA, is the applicant of record for K262419.
How long did the K262419 review take?
FDA received the submission on Jul 15, 2026 and issued its decision on Aug 14, 2026, 30 days later.