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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 / October 2025 / K252806

510(k) cleared

Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)

Shanghai AnQing Medical Instrument Co., Ltd. · Oct 3, 2025 · K252806

FDA cleared the Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) from Shanghai AnQing Medical Instrument Co., Ltd. on Oct 3, 2025 under K252806, 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 Sep 3, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Shanghai AnQing Medical Instrument Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K254251 (InnovexView (GC146-17, GC150-20, GC155-23)), K252598 (Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)).

Questions & Answers

What did FDA clear under K252806?

K252806 is the FDA 510(k) for Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.), submitted by Shanghai AnQing Medical Instrument Co., Ltd.. FDA's decision date was Oct 3, 2025, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)?

Shanghai AnQing Medical Instrument Co., Ltd., based in Shanghai, is the applicant of record for K252806.

How long did the K252806 review take?

FDA received the submission on Sep 3, 2025 and issued its decision on Oct 3, 2025, 30 days later.

← All decisions in October 2025

Sources