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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 / K262552

510(k) cleared

Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)

Scivita Medical Technology Co., Ltd. · Aug 14, 2026 · K262552

FDA cleared the Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) from Scivita Medical Technology Co., Ltd. on Aug 14, 2026 under K262552, a special 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 Jul 24, 2026. The decision came 21 days later, inside the 90 FDA-day goal for a 510(k).

Scivita Medical Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K251338 (Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)).

Questions & Answers

What did FDA clear under K262552?

K262552 is the FDA 510(k) for Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B), submitted by Scivita Medical Technology Co., Ltd.. FDA's decision date was Aug 14, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)?

Scivita Medical Technology Co., Ltd., based in Suzhou, is the applicant of record for K262552.

How long did the K262552 review take?

FDA received the submission on Jul 24, 2026 and issued its decision on Aug 14, 2026, 21 days later.

← All decisions in August 2026

Sources