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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 K260972
Device Name OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD Monitor
Applicant
Sony Corporation
5-1-1, Minatomirai
Nishi-Ku
Yokohama-Shi,  JP 220-8750
Applicant Contact Hideaki Kawano
Correspondent
Sony Corporation
5-1-1, Minatomirai
Nishi-Ku
Yokohama-Shi,  JP 220-8750
Correspondent Contact Hideaki Kawano
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/24/2026
Decision Date 08/26/2026
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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