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Flexstent Biliary Self-Expanding Stent System

by Flexible Stenting Solutions, Inc. 510(k)

Active United States

510(k) K112522

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK112522 Date30 Dec 2011ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1509-2013 FDA Class II initiated 23 Apr 2013

    Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.

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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