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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 / July 2026 / K260516

510(k) cleared

BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)

MacroLux Medical Technology Co., Ltd. · Jul 20, 2026 · K260516

FDA cleared the BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) from MacroLux Medical Technology Co., Ltd. on Jul 20, 2026 under K260516, 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 Feb 17, 2026. The decision came 153 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

MacroLux Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260420 (LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)).

Questions & Answers

What did FDA clear under K260516?

K260516 is the FDA 510(k) for BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR), submitted by MacroLux Medical Technology Co., Ltd.. FDA's decision date was Jul 20, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)?

MacroLux Medical Technology Co., Ltd., based in Shenzhen, is the applicant of record for K260516.

How long did the K260516 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Jul 20, 2026, 153 days later.

← All decisions in July 2026

Sources