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FDA 510(k)

WallFlex Biliary PLUS RX Stent System

K-Number: K242950 · 2024-12-06

Decision Date2024-12-06
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

WallFlex Biliary PLUS RX Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K242950. 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 PLUS RX Stent System?

WallFlex Biliary PLUS RX Stent System is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Boston Scientific. The 510(k) number is K242950.

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

WallFlex Biliary PLUS RX Stent System received FDA 510(k) clearance on 2024-12-06, under 510(k) number K242950.

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

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

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

The FDA product code for WallFlex Biliary PLUS 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 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.