WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / 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.

Anhui Happiness Workshop Instruments Co., Ltd. has one other decision in the tracker over the last 12 months: K250128 (Single Use Suction-Evacuation Ureteral Access Sheath).

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

Sources