510(k) K250890
K250890 is an FDA 510(k) premarket notification submitted by Sioxmed, LLC for the device "SBC1 Cream". The FDA issued a decision of Substantially Equivalent on January 12, 2026. 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
- January 12, 2026
- Date Received
- March 25, 2025
- 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