510(k) clearance

Single Use Ureteral Access Sheath

FDA 510(k) source

510(k) number

K260410

Applicant

Zhejiang Chuangxiang Medical Technology Co., Ltd.

Decision date

Sep 11, 2026

Date received

Feb 9, 2026

Decision

Substantially Equivalent

Clearance type

Special

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

Hangzhou, CN