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FlexStent Biliary Self-Expanding Stent System

by Flexible Stenting Solutions, Inc. 510(k)

Active United States Open recall

510(k) K121125

Regulatory status

as of 29 Oct 2026

Recall ongoing. 6 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK121125 Date6 Jul 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

7 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-0218-2022 FDA Class II initiated 1 Oct 2021
    • Ongoing Z-0220-2022 FDA Class II initiated 1 Oct 2021
    • Ongoing Z-0221-2022 FDA Class II initiated 1 Oct 2021
    • Ongoing Z-0219-2022 FDA Class II initiated 1 Oct 2021
    • Ongoing Z-0216-2022 FDA Class II initiated 1 Oct 2021
    • Ongoing Z-0217-2022 FDA Class II initiated 1 Oct 2021

    There is a potential for distal tip dislodgement or separation.

    • Terminated Z-0324-2018 FDA Class II initiated 15 Nov 2017

    Potential for cracked luer hubs

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
SESU

Overview

AI-generated summary, 19 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 FlexStent Biliary Self-Expanding Stent System is a self-expanding stent designed for use in the biliary ducts. It is classified as a stent, drain, and dilator for biliary duct applications under the FDA’s classification system. This device is intended to maintain patency in malignant biliary strictures by providing mechanical support to the bile ducts, reducing obstruction and improving bile flow.

The system is supplied as a single-use, sterile device and is intended for use in clinical settings such as endoscopy or interventional radiology. It is available in various diameters and lengths, including sizes up to 10 mm in diameter and lengths up to 100 mm. The device has received FDA 510(k) clearance and is regulated under the classification for Class II medical devices (876.5010). No MRI safety information is specified in the provided data.

Other devices from Flexible Stenting Solutions, Inc.

Questions

AI-generated answers, 19 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 clinical procedures is the FlexStent Biliary Self-Expanding Stent System intended to support, and where would it typically be used?

    The FlexStent Biliary Self-Expanding Stent System is designed to maintain patency in malignant biliary strictures by providing mechanical support to bile ducts, reducing obstruction, and improving bile flow. It is intended for use in clinical settings such as endoscopy or interventional radiology, where biliary duct interventions are performed. The device is specifically classified under the FDA’s system for stents, drains, and dilators for biliary duct applications.

  • Is the FlexStent Biliary Self-Expanding Stent System reusable, or is it meant for single-use only?

    The FlexStent Biliary Self-Expanding Stent System is explicitly supplied as a single-use, sterile device, meaning it is intended for one-time use in a clinical setting and should not be reused. This aligns with standard practices for self-expanding stents to ensure patient safety and sterility.

  • What sizes and configurations are available for the FlexStent Biliary Self-Expanding Stent System, and how might this affect my selection?

    The FlexStent Biliary Self-Expanding Stent System is available in various diameters (up to 10 mm) and lengths (up to 100 mm), allowing for customization based on patient anatomy and clinical needs. This range enables clinicians to choose a stent size that best fits the biliary duct’s specific dimensions to ensure proper placement and patency.

  • How should the FlexStent Biliary Self-Expanding Stent System be stored, and are there any special handling requirements?

    Since the device is sterile and single-use, it should be stored in its original packaging under clean, dry conditions away from direct sunlight or extreme temperatures. The packaging is designed to maintain sterility until use, so it should remain unopened until deployment in a clinical setting. Always follow manufacturer instructions for storage to preserve device integrity.

  • What regulatory pathway was followed for the FlexStent Biliary Self-Expanding Stent System, and how does this affect its use in clinical practice?

    The FlexStent Biliary Self-Expanding Stent System received FDA 510(k) clearance, which means it was determined to be substantially equivalent to a legally marketed predicate device. This regulatory pathway ensures that the device meets FDA safety and effectiveness standards for its intended use in maintaining biliary duct patency. Clinicians can rely on this clearance as part of their decision-making process when selecting the device for procedures.