510(k) clearance

Endox High Level Disinfectant

FDA 510(k) source

510(k) number

K254094

Applicant

Whiteley USA, Inc.

Decision date

Oct 16, 2026

Date received

Dec 19, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

MED

Device type

Sterilant, Medical Devices

Device class

Class II

Regulation

21 CFR 880.6885

Advisory committee

General Hospital

Statement or summary

Summary

Third party

N

Location

Wilmington, DE, US