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Ureteral Dilator

by American Edwards Laboratories 510(k)

Active United States

510(k) K840746

Overview

The Ureteral Dilator is a medical instrument used to gradually widen the ureter to facilitate passage of catheters or to treat ureteral strictures. It is classified as a Class II device under product code KOE and is intended for use in urology procedures.

This device is supplied by American Edwards Laboratories and is regulated under 21 CFR 876.5520. It has received FDA 510(k) clearance with number K840746 and is reviewed by the Gastroenterology, Urology advisory committee. The device is available in various sizes as indicated by the multiple registration numbers provided.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840746 Date13 Apr 1984ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KOE
Device Class
Class II
Regulation
21 CFR Part 876.5520
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from American Edwards Laboratories

See all devices from American Edwards Laboratories →

Questions

  • What is the Ureteral Dilator used for?

    The Ureteral Dilator is a medical instrument used to gradually widen the ureter to facilitate passage of catheters or to treat ureteral strictures during urology procedures.

  • How is the Ureteral Dilator supplied?

    The Ureteral Dilator is supplied by American Edwards Laboratories and is available in various sizes as indicated by the multiple registration numbers provided.

  • What is the regulatory status of the Ureteral Dilator?

    The Ureteral Dilator is classified as a Class II device under product code KOE and has received FDA 510(k) clearance with number K840746. It is regulated under 21 CFR 876.5520.

  • Is the Ureteral Dilator single-use or reusable?

    The device data does not specify whether the Ureteral Dilator is designed for single-use or multiple uses. This information should be obtained directly from the manufacturer or product documentation.