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FDA 510(k)

COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION

K-Number: K903858 · 1990-10-10

ApplicantCook, Inc.
Decision Date1990-10-10
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1990-10-10 under 510(k) number K903858. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION?

COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-10-10. The listed applicant is Cook, Inc.. The 510(k) number is K903858.

When did COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION receive FDA 510(k) clearance?

COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION received FDA 510(k) clearance on 1990-10-10, under 510(k) number K903858.

Who is the listed applicant for COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION?

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 COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION?

The FDA product code for COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION 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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