K243457
- 510(k) number
- K243457
- Device name
- Nixall Antimicrobial Solutions Skin & Wound Hydrogel
- Applicant
- Seriously Clean, Ltd. MO · US
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-05-02
- Date received
- 2024-11-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243457.pdf
Official FDA record: K243457
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.