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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 / March 2026 / K253184

510(k) cleared

Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)

Zhuhai Wesee Meditech Co., Ltd. · Mar 25, 2026 · K253184

FDA cleared the Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) from Zhuhai Wesee Meditech Co., Ltd. on Mar 25, 2026 under K253184, a traditional 510(k). The device falls under product code EOB, Nasopharyngoscope (Flexible Or Rigid), regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Sep 26, 2025. The decision came 180 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 Zhuhai Wesee Meditech Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253184?

K253184 is the FDA 510(k) for Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B), submitted by Zhuhai Wesee Meditech Co., Ltd.. FDA's decision date was Mar 25, 2026, under product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Who makes the Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)?

Zhuhai Wesee Meditech Co., Ltd., based in Zhuhai, is the applicant of record for K253184.

How long did the K253184 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Mar 25, 2026, 180 days later.

← All decisions in March 2026