Cleared Traditional

Single Use Ureteral Access Sheath

K220065 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology

May 2022

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K220065 is an FDA 510(k) clearance for the Single Use Ureteral Access Sheath, a Endoscopic Access Overtube, Gastroenterology-urology (Class II — Special Controls, product code FED), submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 25, 2022, 135 days after receiving the submission on January 10, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K220065 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2022
Decision Date	May 25, 2022
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FED — Endoscopic Access Overtube, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Facilitate Passage And Aid Advancement Of Endoscopes Into The Body, Especially In Cases Of Repeated Intubation.