Cleared Special

K260410 - Single Use Ureteral Access Sheath

K260410 is an FDA 510(k) clearance for Single Use Ureteral Access Sheath, manufactured by Zhejiang Chuangxiang Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FED cleared through the Special 510(k) pathway after a 214-day FDA review.

K260410 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2026
Decision
214d
Days
Class 2
Risk

K260410 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 September 11, 2026 after a review of 214 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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

FDA 510(k) Submission Details - K260410

510(k) Number K260410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2026
Decision Date September 11, 2026
Days to Decision 214 days
Submission Type Special
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
83d slower than avg
Panel avg: 131d · This submission: 214d
Pathway characteristics
Modification to existing cleared device.

FED Device Classification - Class 2, Special Controls

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 95
Devices cleared under the same product code (FED) and FDA review panel - the closest regulatory comparables to K260410.
Pathfinder Endoscope Overtube
K262262 · Neptune Medical, Inc. · Sep 2026
Navigator™ Flex Ureteral Access Sheath Set
K261915 · Boston Scientific Corporation · Aug 2026
CVAC Aspiration System
K260965 · Calyxo, Inc. · Apr 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
K260521 · Zhuhai Pusen Medical Technology Co., Ltd. · Apr 2026
Prodeon Urethral Sheath System
K252572 · Prodeon Medical, Inc. · Oct 2025
Single Use Suction-Evacuation Ureteral Access Sheath
K250128 · Anhui Happiness Workshop Medical Instruments Co., Ltd. · Sep 2025