Cleared Traditional

SiOxC Cream

K242406 · Sioxmed, LLC · General & Plastic Surgery
Mar 2025
Decision
211d
Days
Risk

About This 510(k) Submission

K242406 is an FDA 510(k) clearance for the SiOxC Cream, a Dressing, Wound, Drug, submitted by Sioxmed, LLC (Clemmons, US). The FDA issued a Cleared decision on March 13, 2025, 211 days after receiving the submission on August 14, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K242406 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2024
Decision Date March 13, 2025
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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