Protege EverFlex Self-Expanding Biliary Stent System
FDA 510(k)Class II (US FDA 510(k))
by Ev3, Inc
Identifiers
- 510(k) Number
- K060057 FDA 510(k)
- FDA Product Code
- FGE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5010 FDA 510(k)
- Regulation Number
- 876.5010 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The Protege EverFlex Self-Expanding Biliary Stent System is a self-expanding stent designed for placement within the biliary ducts. It falls under the category of stents, drains, and dilators for biliary use, as classified by regulatory authorities. This device is intended to maintain patency in the biliary tree, particularly in cases of obstruction or strictures, by providing mechanical support to the ductal walls. Constructed from a self-expanding material, it ensures radial force to keep the lumen open once deployed.
The system is supplied as a sterile, single-use device and is deployed via an over-the-wire delivery system. It is intended for use in both diagnostic and therapeutic endoscopy procedures, typically under fluoroscopic guidance. The stents are available in lengths ranging from 20 mm to 120 mm, with radiopaque tantalum markers for enhanced visibility during imaging. Regulatory clearance for this device was granted under the FDA’s 510(k) pathway, with a classification as a Class II medical device under the regulation number 876.5010.
Frequently asked questions
What clinical scenarios is the Protege EverFlex Self-Expanding Biliary Stent System intended to address within the biliary tree?
The Protege EverFlex Self-Expanding Biliary Stent System is designed to maintain patency in the biliary ducts, particularly in cases where obstruction or strictures occur. It provides mechanical support to the ductal walls to keep the lumen open, which is critical for managing bile flow in patients with conditions like biliary strictures, tumors, or other obstructions that impede drainage.
How is the Protege EverFlex stent deployed, and what imaging guidance is recommended during the procedure?
The Protege EverFlex stent is deployed via an over-the-wire delivery system, which allows for precise placement within the biliary ducts. The procedure is typically performed under fluoroscopic guidance to ensure accurate positioning and deployment, as the stent includes radiopaque tantalum markers for enhanced visibility during imaging.
Are the Protege EverFlex stents reusable, and what are the available lengths for ordering?
The Protege EverFlex Self-Expanding Biliary Stent System is supplied as a sterile, single-use device, meaning each stent is intended for one-time use only. Available lengths range from 20 mm to 120 mm, allowing clinicians to select the appropriate size based on the patient’s anatomical needs.
What regulatory pathway was followed for clearance of the Protege EverFlex stent, and what classification does it hold?
The Protege EverFlex stent received FDA clearance under the 510(k) pathway, specifically classified as a Class II medical device under regulation number 876.5010. This classification aligns with its use as a stent, drain, or dilator for biliary applications, ensuring it meets stringent safety and performance standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Protégé™ EverFlex™ Self-Expanding Biliary Stent System, EverFlex™ Stent System with Entrust™ Delivery System, PDF EverFlex™ - Food and Drug Administration, PDF Protégé EverFlex Self-Expanding Stent System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060057 | Class II | Active |
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Manufacturer
- Manufacturer
- Ev3, Inc
- FDA Applicant
- Ev3, Inc.
Sources (1)
- FDA 510(k) K060057 24 fields · synced Sep 20, 2026