Medivators Dsd Edge Endoscope Reprocessing System

• • Ongoing Z-2539-2024 FDA Class II ·initiated 13 Jun 2024

  IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection

510(k) Number

K092387 ↗

FDA Product Code

FEB

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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