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The Tracker / September 2026 / K260512

510(k) cleared

Disposable Ureteral Access Sheath

Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Sep 21, 2026 · K260512

FDA cleared the Disposable Ureteral Access Sheath from Yangzhou Fartley Medical Instrument Technology Co., Ltd. on Sep 21, 2026 under K260512, a traditional 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, 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 17, 2026. The decision came 216 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Yangzhou Fartley Medical Instrument Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K260423 (Disposable Endoscopic Distal Attachments).

Questions & Answers

What did FDA clear under K260512?

K260512 is the FDA 510(k) for Disposable Ureteral Access Sheath, submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd.. FDA's decision date was Sep 21, 2026, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Disposable Ureteral Access Sheath?

Yangzhou Fartley Medical Instrument Technology Co., Ltd., based in Yangzhou, is the applicant of record for K260512.

How long did the K260512 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Sep 21, 2026, 216 days later.

← All decisions in September 2026

Sources