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The Tracker / December 2025 / K252468

510(k) cleared

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)

Zhejiang Geyi Medical Instrument Co., Ltd. · Dec 16, 2025 · K252468

FDA cleared the Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) from Zhejiang Geyi Medical Instrument Co., Ltd. on Dec 16, 2025 under K252468, 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 Aug 6, 2025. The decision came 132 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Zhejiang Geyi Medical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252468?

K252468 is the FDA 510(k) for Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121), submitted by Zhejiang Geyi Medical Instrument Co., Ltd.. FDA's decision date was Dec 16, 2025, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)?

Zhejiang Geyi Medical Instrument Co., Ltd., based in Jiande City, is the applicant of record for K252468.

How long did the K252468 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Dec 16, 2025, 132 days later.

← All decisions in December 2025