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FDA 510(k)

BULLSEYE BILIARY STENT SYSTEM

K-Number: K082093 · 2009-07-29

ApplicantSquareone
Decision Date2009-07-29
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

BULLSEYE BILIARY STENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Squareone. It received FDA 510(k) clearance on 2009-07-29 under 510(k) number K082093. 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 BULLSEYE BILIARY STENT SYSTEM?

BULLSEYE BILIARY STENT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-29. The listed applicant is Squareone. The 510(k) number is K082093.

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

BULLSEYE BILIARY STENT SYSTEM received FDA 510(k) clearance on 2009-07-29, under 510(k) number K082093.

Who is the listed applicant for BULLSEYE BILIARY STENT SYSTEM?

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

What is the FDA product code for BULLSEYE BILIARY STENT SYSTEM?

The FDA product code for BULLSEYE BILIARY STENT SYSTEM 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.

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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