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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 K253531
Device Name Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
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 Received11/13/2025
Decision Date 02/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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