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Endura Ureteral Stent and Stent Set

by Cathegenix (Xiamen) Co., Ltd.

510(k) K251469

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK251469 Date19 Dec 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FAD
Device Class
Class II
Regulation
21 CFR Part 876.4620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESK Substantially Equivalent — Kit

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Endura Ureteral Stent and Stent Set is a ureteral stent, which is a type of medical device used for upper urinary tract drainage and stone management. It is designed to provide reliable support for extended indwelling needs. The device has a hydrophilic surface and anti-encrustation properties.

The Endura Ureteral Stent and Stent Set is supplied with a product code of FAD and is regulated under 21 CFR 876.4620. It has been authorized under FDA 510(k) with the reference number K251469. The device is intended for use in gastroenterology and urology settings.

Other devices from Cathegenix (Xiamen) Co., Ltd.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Endura Ureteral Stent and Stent Set used for?

    The Endura Ureteral Stent and Stent Set is used for upper urinary tract drainage and stone management, providing reliable support for extended indwelling needs.

  • What are the key features of the Endura Ureteral Stent and Stent Set?

    The device has a hydrophilic surface and anti-encrustation properties, making it suitable for use in gastroenterology and urology settings.

  • Is the Endura Ureteral Stent and Stent Set regulated by the FDA?

    Yes, the Endura Ureteral Stent and Stent Set has been authorized under FDA 510(k) with the reference number K251469, and is regulated under 21 CFR 876.4620.

  • What is the product code for the Endura Ureteral Stent and Stent Set?

    The product code for the Endura Ureteral Stent and Stent Set is FAD.