Dynalink .035 Biliary Self-Expanding Stent System, Models 1010102-38, 1010102-56, 1010102-80, 1010103-38, 1010103-56, 101010

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K021824 ↗

FDA Product Code

FGE

Models / Variants

1010102-38

1010102-56

1010102-80

1010103-38

1010103-56

101010

Device Class

Class II

Regulation

21 CFR Part 876.5010

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESU

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