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FDA 510(k)

MODIFICATION TO: ZILVER 635 BILIARY STENT

K-Number: K043481 · 2004-12-29

ApplicantCook, Inc.
Decision Date2004-12-29
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

MODIFICATION TO: ZILVER 635 BILIARY STENT is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2004-12-29 under 510(k) number K043481. 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 MODIFICATION TO: ZILVER 635 BILIARY STENT?

MODIFICATION TO: ZILVER 635 BILIARY STENT is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Cook, Inc.. The 510(k) number is K043481.

When did MODIFICATION TO: ZILVER 635 BILIARY STENT receive FDA 510(k) clearance?

MODIFICATION TO: ZILVER 635 BILIARY STENT received FDA 510(k) clearance on 2004-12-29, under 510(k) number K043481.

Who is the listed applicant for MODIFICATION TO: ZILVER 635 BILIARY STENT?

The FDA 510(k) record lists Cook, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: ZILVER 635 BILIARY STENT?

The FDA product code for MODIFICATION TO: ZILVER 635 BILIARY STENT is FGE.

Related Clinical Trials

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.

Other records listing Cook, Inc. 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.

View all 184 devices →

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

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

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