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The Tracker / April 2026 / K252929

510(k) cleared

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

Anhui Happiness Workshop Instruments Co., Ltd. · Apr 9, 2026 · K252929

FDA cleared the Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) from Anhui Happiness Workshop Instruments Co., Ltd. on Apr 9, 2026 under K252929, 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 Sep 15, 2025. The decision came 206 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 Anhui Happiness Workshop Instruments Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252929?

K252929 is the FDA 510(k) for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200), submitted by Anhui Happiness Workshop Instruments Co., Ltd.. FDA's decision date was Apr 9, 2026, under product code FGB (Ureteroscope And Accessories, Flexible/Rigid).

Who makes the Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

Anhui Happiness Workshop Instruments Co., Ltd., based in Bengbu, is the applicant of record for K252929.

How long did the K252929 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Apr 9, 2026, 206 days later.

← All decisions in April 2026