WHERE ARE YOU?

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

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / June 2026 / K261260

510(k) cleared

HD Camera Head OLYMPUS CH-S200-08-LB

Olympus Medical Systems Corporation · Jun 24, 2026 · K261260

FDA cleared the HD Camera Head OLYMPUS CH-S200-08-LB from Olympus Medical Systems Corporation on Jun 24, 2026 under K261260, 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 Apr 16, 2026. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

Olympus Medical Systems Corporation has 8 other decisions in the tracker over the last 12 months: K262079 (4K Camera Head OLYMPUS CH-S700-08-LB), K260401 (EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)), K260824 (Gastrointestinal Videoscope Olympus GIF-2T1500), K260856 (Disposable Distal Attachment D-201-13404).

Questions & Answers

What did FDA clear under K261260?

K261260 is the FDA 510(k) for HD Camera Head OLYMPUS CH-S200-08-LB, submitted by Olympus Medical Systems Corporation. FDA's decision date was Jun 24, 2026, under product code FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology).

Who makes the HD Camera Head OLYMPUS CH-S200-08-LB?

Olympus Medical Systems Corporation, based in Hachioji-Shi, is the applicant of record for K261260.

How long did the K261260 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Jun 24, 2026, 69 days later.

← All decisions in June 2026