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FDA 510(k)

Endox High Level Disinfectant

K-Number: K254094 · 2026-10-16

ApplicantWhiteley USA, Inc.
Decision Date2026-10-16
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Endox High Level Disinfectant is the device name listed in this FDA 510(k) record. The listed applicant is Whiteley USA, Inc.. It received FDA 510(k) clearance on 2026-10-16 under 510(k) number K254094. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endox High Level Disinfectant?

Endox High Level Disinfectant is a medical device that received FDA 510(k) clearance on 2026-10-16. The listed applicant is Whiteley USA, Inc.. The 510(k) number is K254094.

When did Endox High Level Disinfectant receive FDA 510(k) clearance?

Endox High Level Disinfectant received FDA 510(k) clearance on 2026-10-16, under 510(k) number K254094.

Who is the listed applicant for Endox High Level Disinfectant?

The FDA 510(k) record lists Whiteley USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endox High Level Disinfectant?

The FDA product code for Endox High Level Disinfectant is MED.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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