FDA cleared the Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) from Applied Medical Resources Corporation on Feb 23, 2026 under K253531, a traditional 510(k). The device falls under product code KGW, Ring (Wound Protector), Drape Retention, Internal, regulated at 21 CFR 878.4370 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Nov 13, 2025. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
Applied Medical Resources Corporation has 5 other decisions in the tracker over the last 12 months: K260982 (Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)), K252740 (Voyant® Open Fusion Device (EB240/Open Fusion)), K252412 (Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)), K252442 (Kii Structural Balloon Access System).