510(k) K253531

Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) by Applied Medical Resources Corporation — Product Code KGW

K253531 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corporation for the device "Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)". The FDA issued a decision of Substantially Equivalent on February 23, 2026. The device falls under product code KGW (Ring (Wound Protector), Drape Retention, Internal), a Class II device regulated under 21 CFR 878.4370. Applied Medical Resources Corporation has at least 10 other 510(k) clearances on record.