510(k) K242406
K242406 is an FDA 510(k) premarket notification submitted by Sioxmed, LLC for the device "SiOxC Cream". The FDA issued a decision of Substantially Equivalent on March 13, 2025. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sioxmed, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2025
- Date Received
- August 14, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type