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Rusch Polyflex Stent for the Esophagus with Introducer System

by Rusch Intl.

510(k) K010068

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK010068 Date8 Feb 2001ClearedStatusActive

Recalls

9 recalls · FDA

  • 9 recalls, same reason

    • Terminated Z-0821-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0824-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0822-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0823-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0820-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0826-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0818-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0825-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003
    • Terminated Z-0819-03 FDA Unclassified (pre-2012) initiated 16 Apr 2003

    Radiopaque marker bands may not be visible under fluoroscopy

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  • Withdrawn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
ESW
Device Class
Class II
Regulation
21 CFR Part 878.3610
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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