Cook Zilver Biliary Stent
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K010242 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 Cook Zilver Biliary Stent is a self-expanding stent designed for use in the biliary ducts. Classified as a stent, drain, and dilator for biliary applications, it is intended to maintain patency in the biliary tree, particularly in cases involving malignant obstructions. Constructed from nitinol, the stent provides radial force and flexibility to support long-term lumen maintenance while minimizing tissue compression.
This stent is supplied in lengths of 4, 6, 8, 10, and 12 cm and features a 6 Fr introducer. It is intended for single-use and is not reusable. The device is regulated under FDA 510(k) clearance (K010242) and falls under the classification of Class II medical devices (876.5010). Sterility and MRI safety specifications are not explicitly detailed in the provided data, but it is intended for use in clinical settings where biliary drainage is required, such as endoscopy or interventional radiology procedures.
Frequently asked questions
What is the Cook Zilver Biliary Stent used for?
The Cook Zilver Biliary Stent is designed to maintain patency (open passage) in the biliary ducts, particularly in cases involving malignant obstructions. Its self-expanding nitinol construction provides radial force to keep the bile ducts open while minimizing tissue compression, ensuring long-term drainage for patients requiring biliary intervention.
How is the Cook Zilver Biliary Stent supplied, and what sizes are available?
The stent is supplied in a pre-loaded delivery system with a 6 French (Fr) introducer. Available lengths include 4 cm, 6 cm, 8 cm, 10 cm, and 12 cm, allowing clinicians to select the appropriate size based on the patient’s anatomy and clinical needs. The delivery system is optimized for use in endoscopy or interventional radiology procedures.
Is the Cook Zilver Biliary Stent intended for single-use or reuse?
The Cook Zilver Biliary Stent is explicitly designed for single-use only. It is not intended for reuse or reprocessing, as this could compromise its structural integrity, sterility, or performance. Single-use ensures patient safety and compliance with clinical best practices for biliary stents.
What materials is the Cook Zilver Biliary Stent made from, and why does it matter?
The stent is constructed from nitinol, a shape-memory alloy known for its flexibility and radial force. This material allows the stent to self-expand within the biliary ducts while conforming to the anatomy, reducing the risk of tissue compression or migration. Nitinol’s durability and biocompatibility also support long-term patency in obstructive conditions.
How should the Cook Zilver Biliary Stent be stored before use?
While specific storage instructions are not detailed in the provided data, self-expanding stents like the Cook Zilver Biliary Stent typically require protection from moisture, extreme temperatures, and physical damage. The delivery system should be stored in its original packaging until use, following manufacturer guidelines to preserve sterility and functionality. Always refer to the included instructions for storage details.
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: Zilver 635® Biliary Self-Expanding Stent - Cook Medical, Zilver 635® Biliary Self-Expanding Stent - Cook Medical, Biliary Therapy | Cook Medical, Zilver 635® Biliary Self-Expanding Stent - Cook Medical, COOK Medical Zilver 635 Instructions For Use Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010242 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K010242 24 fields · synced Oct 1, 2026