Rx Herculink Elite Biliary Stent System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K053454 ↗

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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See all devices from Guidant Corp. →