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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 / K262079

510(k) cleared

4K Camera Head OLYMPUS CH-S700-08-LB

Olympus Medical Systems Corp. · Sep 10, 2026 · K262079

FDA cleared the 4K Camera Head OLYMPUS CH-S700-08-LB from Olympus Medical Systems Corp. on Sep 10, 2026 under K262079, a traditional 510(k). The device falls under product code FET, Endoscopic Video Imaging System/Component, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 22, 2026. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

Olympus Medical Systems Corp. has 8 other decisions in the tracker over the last 12 months: K260401 (EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)), K260824 (Gastrointestinal Videoscope Olympus GIF-2T1500), K260856 (Disposable Distal Attachment D-201-13404), K261183 (EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)).

Questions & Answers

What did FDA clear under K262079?

K262079 is the FDA 510(k) for 4K Camera Head OLYMPUS CH-S700-08-LB, submitted by Olympus Medical Systems Corp.. FDA's decision date was Sep 10, 2026, under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology).

Who makes the 4K Camera Head OLYMPUS CH-S700-08-LB?

Olympus Medical Systems Corp., based in Tokyo, is the applicant of record for K262079.

How long did the K262079 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Sep 10, 2026, 80 days later.

← All decisions in September 2026