Zilver 635 Biliary Stent
K-Number: K163018 · 2016-12-23
Device Summary
Frequently Asked Questions
What is the Zilver 635 Biliary Stent?
Zilver 635 Biliary Stent is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K163018.
When did Zilver 635 Biliary Stent receive FDA 510(k) clearance?
Zilver 635 Biliary Stent received FDA 510(k) clearance on 2016-12-23, under 510(k) number K163018.
Who is the listed applicant for Zilver 635 Biliary Stent?
The FDA 510(k) record lists Cook Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Zilver 635 Biliary Stent?
The FDA product code for Zilver 635 Biliary Stent is FGE.
Other records listing Cook Ireland, Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FGE)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.