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Wallstent Transhepatic Biliary Endoprosthesis

by Boston Scientific Scimed, Inc. 2 variants

510(k) K964119

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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)SESE Substantially Equivalent · Traditional NumberK964119 Date28 Apr 1997ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0609-2007 FDA Unclassified (pre-2012) initiated 20 Dec 2006
    • Terminated Z-0608-2007 FDA Unclassified (pre-2012) initiated 20 Dec 2006
    • Terminated Z-0605-2007 FDA Unclassified (pre-2012) initiated 20 Dec 2006
    • Terminated Z-0604-2007 FDA Unclassified (pre-2012) initiated 20 Dec 2006
    • Terminated Z-0606-2007 FDA Unclassified (pre-2012) initiated 20 Dec 2006
    • Terminated Z-0607-2007 FDA Unclassified (pre-2012) initiated 20 Dec 2006

    Guidewire restriction during use (excessive adhesive in the guidewire lumen)

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  • Withdrawn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
SESE Substantially Equivalent

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