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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K252442
Device Name Kii Structural Balloon Access System
Applicant
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact Derek Greene
Correspondent
Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact Derek Greene
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/04/2025
Decision Date 10/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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