Cleared Traditional

Single Use Ureteral Access Sheath (K220065) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220065 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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May 2022
Decision
135d
Days
Class 2
Risk

K220065 is an FDA 510(k) clearance for the Single Use Ureteral Access Sheath. Classified as Endoscopic Access Overtube, Gastroenterology-urology (product code FED), Class II - Special Controls.

Submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on May 25, 2022 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Chuangxiang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K220065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 130d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FED Endoscopic Access Overtube, Gastroenterology-urology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FED Endoscopic Access Overtube, Gastroenterology-urology

All 48
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K220065.
Over-tube (TR-1208A)
K230752 · Fujifilm Healthcare Americas Corporation · Sep 2023
Disposable Ureteral Access Sheath
K230748 · Youcare Technology Co.,Ltd. (Wuhan) · Aug 2023
Pathfinder Endoscope Overtube with Balloon Device
K230801 · Neptune Medical, Inc. · Jul 2023
Mini PCNL-System
K200770 · Trokamed GmbH · Jul 2021
Pathfinder Endoscope Overtube
K211301 · Neptune Medical, Inc. · May 2021
Disposable Ureteral Access Sheath
K203165 · Suzhou Beyo Medical Technology Co., Ltd. · Apr 2021