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 / 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).

Shanghai AnQing Medical Instrument Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252806 (Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)), K252598 (Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)).

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

Sources