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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 / K262397

510(k) cleared

CuratOR EX2742

Eizo Corporation · Sep 11, 2026 · K262397

FDA cleared the CuratOR EX2742 from Eizo Corporation on Sep 11, 2026 under K262397, a traditional 510(k). The device falls under product code GCJ, Laparoscope, General & Plastic Surgery, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 14, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Eizo Corporation has one other decision in the tracker over the last 12 months: K262783 (RadiForce MX247W).

Questions & Answers

What did FDA clear under K262397?

K262397 is the FDA 510(k) for CuratOR EX2742, submitted by Eizo Corporation. FDA's decision date was Sep 11, 2026, under product code GCJ (Laparoscope, General & Plastic Surgery).

Who makes the CuratOR EX2742?

Eizo Corporation, based in Hakusan, Ishikawa, is the applicant of record for K262397.

How long did the K262397 review take?

FDA received the submission on Jul 14, 2026 and issued its decision on Sep 11, 2026, 59 days later.

← All decisions in September 2026

Sources