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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring (Wound Protector), Drape Retention, Internal
510(k) Number K260982
Device Name 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)
Applicant
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact Apeksha Shanbhag
Correspondent
Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact Apeksha Shanbhag
Regulation Number878.4370
Classification Product Code
KGW  
Subsequent Product Code
FTF  
Date Received03/25/2026
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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