Skip to content

Wallflex Biliary Rx Stent System

by Boston Scientific

510(k) K140630

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK140630 Date23 May 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2958-2020 FDA Class II initiated 7 Aug 2020

    Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FGE
Device class
Class II
Regulation
21 CFR Part 876.5010
Advisory committee
Gastroenterology, Urology
FDA decision
SESU

Other devices from Boston Scientific

See all devices from Boston Scientific →