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The Tracker / February 2026 / K254251

510(k) cleared

InnovexView (GC146-17, GC150-20, GC155-23)

Shanghai AnQing Medical Instrument Co., Ltd. · Feb 26, 2026 · K254251

FDA cleared the InnovexView (GC146-17, GC150-20, GC155-23) from Shanghai AnQing Medical Instrument Co., Ltd. on Feb 26, 2026 under K254251, a traditional 510(k). The device falls under product code HIH, Hysteroscope (And Accessories), regulated at 21 CFR 884.1690 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 29, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K254251?

K254251 is the FDA 510(k) for InnovexView (GC146-17, GC150-20, GC155-23), submitted by Shanghai AnQing Medical Instrument Co., Ltd.. FDA's decision date was Feb 26, 2026, under product code HIH (Hysteroscope (And Accessories)).

Who makes the InnovexView (GC146-17, GC150-20, GC155-23)?

Shanghai AnQing Medical Instrument Co., Ltd., based in Shanghai, is the applicant of record for K254251.

How long did the K254251 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Feb 26, 2026, 59 days later.

← All decisions in February 2026