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FDA 510(k)

WallFlex™ Biliary RX Stent System

K-Number: K223469 · 2023-06-15

Decision Date2023-06-15
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

WallFlex™ Biliary RX Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223469. 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 WallFlex™ Biliary RX Stent System?

WallFlex™ Biliary RX Stent System is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Boston Scientific Corporation. The 510(k) number is K223469.

When did WallFlex™ Biliary RX Stent System receive FDA 510(k) clearance?

WallFlex™ Biliary RX Stent System received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223469.

Who is the listed applicant for WallFlex™ Biliary RX Stent System?

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

What is the FDA product code for WallFlex™ Biliary RX Stent System?

The FDA product code for WallFlex™ Biliary RX 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.

Other records listing Boston Scientific 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.