Rx Herculink 14 Biliary Stent System, Models 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K001224 ↗

FDA Product Code

FGE

Models / Variants

1005127-13

1005129-13

1005131-13

1005133-13

1005135-13

1005137-13

100

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

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

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