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FDA 510(k)

SINGLE USE BILIARY DRAINAGE STENT V

K-Number: K103478 · 2011-02-24

Decision Date2011-02-24
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE USE BILIARY DRAINAGE STENT V is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2011-02-24 under 510(k) number K103478. 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 SINGLE USE BILIARY DRAINAGE STENT V?

SINGLE USE BILIARY DRAINAGE STENT V is a medical device that received FDA 510(k) clearance on 2011-02-24. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K103478.

When did SINGLE USE BILIARY DRAINAGE STENT V receive FDA 510(k) clearance?

SINGLE USE BILIARY DRAINAGE STENT V received FDA 510(k) clearance on 2011-02-24, under 510(k) number K103478.

Who is the listed applicant for SINGLE USE BILIARY DRAINAGE STENT V?

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

What is the FDA product code for SINGLE USE BILIARY DRAINAGE STENT V?

The FDA product code for SINGLE USE BILIARY DRAINAGE STENT V 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 Olympus Medical Systems Corporation 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 86 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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