510(k) clearance

Disposable Ureteral Access Sheath

FDA 510(k) source

510(k) number

K260512

Applicant

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Decision date

Sep 21, 2026

Date received

Feb 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FED

Device type

Endoscopic Access Overtube, Gastroenterology-Urology

Device class

Class II

Regulation

21 CFR 876.1500

Advisory committee

Gastroenterology, Urology

Statement or summary

Summary

Third party

N

Location

Yangzhou, CN