WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262874

510(k) cleared

CraniUS Plate

CraniUS, LLC · Sep 11, 2026 · K262874 · In the directory

FDA cleared the CraniUS Plate from CraniUS, LLC on Sep 11, 2026 under K262874, a special 510(k). The device falls under product code GWO, Plate, Cranioplasty, Preformed, Alterable, regulated at 21 CFR 882.5320 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 14, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

CraniUS, LLC has one other decision in the tracker over the last 12 months: K261058 (CraniUS Plate).

Questions & Answers

What did FDA clear under K262874?

K262874 is the FDA 510(k) for CraniUS Plate, submitted by CraniUS, LLC. FDA's decision date was Sep 11, 2026, under product code GWO (Plate, Cranioplasty, Preformed, Alterable).

Who makes the CraniUS Plate?

CraniUS, LLC, based in Baltimore, MD, is the applicant of record for K262874. The company is listed in the MedDevice Startups directory.

How long did the K262874 review take?

FDA received the submission on Aug 14, 2026 and issued its decision on Sep 11, 2026, 28 days later.

← All decisions in September 2026

Sources

In the startup directory

CraniUS Therapeutics

Neurology & Neurotech · Baltimore, MD