K253531
- 510(k) number
- K253531
- Device name
- Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
- Applicant
- Applied Medical Resources Corporation CA · US
- Product code
- KGW — Ring (Wound Protector), Drape Retention, Internal
- Decision date
- 2026-02-23
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253531.pdf
Official FDA record: K253531
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.