SiOxC Cream

FDA 510(k) K242406 · Sioxmed, LLC

Substantially Equivalent

510(k) numberK242406

Submission

Device name
SiOxC Cream
Applicant
Sioxmed, LLC
Clemmons, NC, US
Received
August 14, 2024
Decision date
March 13, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

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K252023MiraChlor Antimicrobial Wound SolutionFRO · Traditional Letus Corporation03/25/2026SE
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More from Solventum Germany GmbH

510(k)DeviceDecision
K250890SBC1 CreamFRO · Traditional 01/12/2026SE
K241660SiOxD® Wound MatrixQSZ · Special 07/05/2024SE
K232847SiOxD Wound MatrixQSZ · Traditional 12/18/2023SE
K222189SiOxD Wound MatrixQSZ · Traditional 11/18/2022SE

Questions and answers

When was SiOxC Cream cleared by the FDA?

SiOxC Cream (K242406) received a 510(k) decision of Substantially Equivalent on March 13, 2025, 211 days after the submission was received.

What is the product code of K242406?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.