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Cordis Biliary Stent

by Cordis Corp.

510(k) K955728

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955728 Date8 May 1996ClearedStatusActive

Official records

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  • Withdrawn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
FGE
Device class
Class II
Regulation
21 CFR Part 876.5010
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Cordis Biliary Stent is a Stent, Drain, and Dilator for the Biliary Ducts (Product Code: FGE), designed to maintain patency of the bile duct. It is intended for use in endoscopic or percutaneous procedures to relieve biliary obstruction by providing mechanical support and ensuring proper bile flow.

This device is supplied as a single-use, non-sterile product and is regulated under FDA 510(k) clearance (K955728) with a Traditional review process. It is classified as Class II under Special Controls (Regulation Number: 876.5010) and is intended for use in clinical settings such as endoscopy or interventional radiology. No MRI safety information is specified in the provided data.

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