Modification to Rx Herculink 14 Biliary Stent System, Models 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K993588 ↗

FDA Product Code

FGE

Models / Variants

1005126-13

1005128-13

1005130-13

1005132-13

1005134-13

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Guidant Corp. →