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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K261015

510(k) cleared

Solo Scope Colonoscope System

Gi View, Ltd. · Aug 21, 2026 · K261015

FDA cleared the Solo Scope Colonoscope System from Gi View, Ltd. on Aug 21, 2026 under K261015, a traditional 510(k). The device falls under product code FDF, Colonoscope And Accessories, Flexible/Rigid, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 27, 2026. The decision came 147 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Gi View, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261015?

K261015 is the FDA 510(k) for Solo Scope Colonoscope System, submitted by Gi View, Ltd.. FDA's decision date was Aug 21, 2026, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the Solo Scope Colonoscope System?

Gi View, Ltd., based in Ramat Gan, is the applicant of record for K261015.

How long did the K261015 review take?

FDA received the submission on Mar 27, 2026 and issued its decision on Aug 21, 2026, 147 days later.

← All decisions in August 2026