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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 / September 2025 / K252598

510(k) cleared

Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

Shanghai AnQing Medical Instrument Co., Ltd. · Sep 15, 2025 · K252598

FDA cleared the Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) from Shanghai AnQing Medical Instrument Co., Ltd. on Sep 15, 2025 under K252598, a special 510(k). The device falls under product code FAJ, Cystoscope 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 Aug 18, 2025. The decision came 28 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)), K252806 (Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)).

Questions & Answers

What did FDA clear under K252598?

K252598 is the FDA 510(k) for Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US), submitted by Shanghai AnQing Medical Instrument Co., Ltd.. FDA's decision date was Sep 15, 2025, under product code FAJ (Cystoscope And Accessories, Flexible/Rigid).

Who makes the Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?

Shanghai AnQing Medical Instrument Co., Ltd., based in Shanghai, is the applicant of record for K252598.

How long did the K252598 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Sep 15, 2025, 28 days later.

← All decisions in September 2025

Sources