K250890
- 510(k) number
- K250890
- Device name
- SBC1 Cream
- Applicant
- Sioxmed, LLC NC · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2026-01-12
- Date received
- 2025-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250890.pdf
Official FDA record: K250890
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.