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Alimaxx-B Uncovered Biliary Stent System

by Alveolus, Inc.

510(k) K072720

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)SESU Traditional NumberK072720 Date11 Apr 2008ClearedStatusActive

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0805-2010 FDA Unclassified (pre-2012) initiated 28 Jan 2010
    • Terminated Z-0802-2010 FDA Unclassified (pre-2012) initiated 28 Jan 2010
    • Terminated Z-0806-2010 FDA Unclassified (pre-2012) initiated 28 Jan 2010
    • Terminated Z-0804-2010 FDA Unclassified (pre-2012) initiated 28 Jan 2010
    • Terminated Z-0803-2010 FDA Unclassified (pre-2012) initiated 28 Jan 2010
    • Terminated Z-0801-2010 FDA Unclassified (pre-2012) initiated 28 Jan 2010

    Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.

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  • Withdrawn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

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