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FDA 510(k)

Beacon EUS Access System

K-Number: K180037 · 2018-04-26

ApplicantCovidien, LLC
Decision Date2018-04-26
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Beacon EUS Access System is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2018-04-26 under approval number K180037. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Beacon EUS Access System?

Beacon EUS Access System is a medical device that received FDA 510(k) clearance on 2018-04-26. It is manufactured by Covidien, LLC. The 510(k) number is K180037.

When was Beacon EUS Access System approved by the FDA?

Beacon EUS Access System received FDA 510(k) clearance on 2018-04-26, under approval number K180037.

What company makes Beacon EUS Access System?

Beacon EUS Access System is manufactured by Covidien, LLC.

What is the FDA product code for Beacon EUS Access System?

The FDA product code for Beacon EUS Access System is FCG.

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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025)

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Related Devices (Code: FCG)

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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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