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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / August 2026 / K261890

510(k) cleared

52Fr ViSiGi LUX; 52Fr ViSiGi 3D®

Boehringer Laboratories, LLC · Aug 14, 2026 · K261890

FDA cleared the 52Fr ViSiGi LUX; 52Fr ViSiGi 3D® from Boehringer Laboratories, LLC on Aug 14, 2026 under K261890, a special 510(k). The device falls under product code KNT, Tubes, Gastrointestinal (And Accessories), regulated at 21 CFR 876.5980 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 5, 2026. The decision came 70 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Boehringer Laboratories, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261890?

K261890 is the FDA 510(k) for 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®, submitted by Boehringer Laboratories, LLC. FDA's decision date was Aug 14, 2026, under product code KNT (Tubes, Gastrointestinal (And Accessories)).

Who makes the 52Fr ViSiGi LUX; 52Fr ViSiGi 3D®?

Boehringer Laboratories, LLC, based in Phoenixville, PA, is the applicant of record for K261890.

How long did the K261890 review take?

FDA received the submission on Jun 5, 2026 and issued its decision on Aug 14, 2026, 70 days later.

← All decisions in August 2026