WHERE ARE YOU?

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

THE TAPE

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 / K261153

510(k) cleared

LithoVue Elite Digital Flexible Ureteroscope System

Boston Scientific Corporation · Aug 26, 2026 · K261153

FDA cleared the LithoVue Elite Digital Flexible Ureteroscope System from Boston Scientific Corporation on Aug 26, 2026 under K261153, a traditional 510(k). The device falls under product code FGB, Ureteroscope 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 Apr 8, 2026. The decision came 140 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K253692 (AVVIGO+ Multi-Modality Guidance System), K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261915 (Navigator Flex Ureteral Access Sheath Set), K261488 (OBSIDIO Conformable Embolic).

Questions & Answers

What did FDA clear under K261153?

K261153 is the FDA 510(k) for LithoVue Elite Digital Flexible Ureteroscope System, submitted by Boston Scientific Corporation. FDA's decision date was Aug 26, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the LithoVue Elite Digital Flexible Ureteroscope System?

Boston Scientific Corporation, based in Marlborough, MA, is the applicant of record for K261153.

How long did the K261153 review take?

FDA received the submission on Apr 8, 2026 and issued its decision on Aug 26, 2026, 140 days later.

← All decisions in August 2026