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FDA 510(k)

FANELLI BILIARY STENT

K-Number: K010601 · 2001-11-16

ApplicantCook, Inc.
Decision Date2001-11-16
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FANELLI 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 2001-11-16 under 510(k) number K010601. 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 FANELLI BILIARY STENT?

FANELLI BILIARY STENT is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Cook, Inc.. The 510(k) number is K010601.

When did FANELLI BILIARY STENT receive FDA 510(k) clearance?

FANELLI BILIARY STENT received FDA 510(k) clearance on 2001-11-16, under 510(k) number K010601.

Who is the listed applicant for FANELLI 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 FANELLI BILIARY STENT?

The FDA product code for FANELLI 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.

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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.

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