Uropass Ureteral Access Sheath, Model 61224

• • Ongoing Z-0364-2025 FDA Class II ·initiated 11 Sep 2024

  Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

• • Ongoing Z-2401-2023 FDA Class II ·initiated 19 May 2023

  Dilator tips may break in the package and in patients during surgical procedures.

510(k) Number

K051593 ↗

FDA Product Code

KNY

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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