Skip to content

WallFlex™ Biliary RX Stent System

by Boston Scientific

510(k) K223469

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK223469 Date15 Jun 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
FDA applicant
Boston Scientific Corporation
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 →