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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 / May 2026 / K260423

510(k) cleared

Disposable Endoscopic Distal Attachments

Yangzhou Fartley Medical Instrument Technology Co., Ltd. · May 28, 2026 · K260423

FDA cleared the Disposable Endoscopic Distal Attachments from Yangzhou Fartley Medical Instrument Technology Co., Ltd. on May 28, 2026 under K260423, a traditional 510(k). The device falls under product code FDF, Colonoscope 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 Feb 9, 2026. The decision came 108 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 Yangzhou Fartley Medical Instrument Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260423?

K260423 is the FDA 510(k) for Disposable Endoscopic Distal Attachments, submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. FDA's decision date was May 28, 2026, under product code FDF (Colonoscope And Accessories, Flexible/Rigid).

Who makes the Disposable Endoscopic Distal Attachments?

Yangzhou Fartley Medical Instrument Technology Co., Ltd., based in Yangzhou, is the applicant of record for K260423.

How long did the K260423 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on May 28, 2026, 108 days later.

← All decisions in May 2026