Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

K-Number: K163169 · 2017-02-07

ApplicantCook Ireland, Ltd.
Decision Date2017-02-07
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-02-07 under approval number K163169. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is a medical device that received FDA 510(k) clearance on 2017-02-07. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K163169.

When was Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent approved by the FDA?

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent received FDA 510(k) clearance on 2017-02-07, under approval number K163169.

What company makes Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?

Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is manufactured by Cook Ireland, Ltd..

What is the FDA product code for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent?

The FDA product code for Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent is FGE.

Related Clinical Trials

NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING NCT05874934 Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String COMPLETED NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT06750146 Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis SUSPENDED NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED

Other Devices by Cook Ireland, Ltd.

K163018Zilver 635 Biliary Stent K162717Evolution Esophageal Stent System – Partially Covered K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle K17161914Fr Colon Decompression Set, Macon Colon Decompression Set K171623Nasal Pancreatic Drainage Set K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

View all 19 devices →

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑