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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 K191678
Device Name IP Converter
Applicant
Sony Electronics, Inc.
115 W. Century Rd., Suite 250
Paramus,  NJ  07652
Applicant Contact Shogo Obuchi
Correspondent
Sony Corporation, Atsugi Technology Center
4-14-1 Asahi-Cho
Atsugi-Shi,  JP 243-0014
Correspondent Contact Tomomichi Iwasaka
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/24/2019
Decision Date 01/10/2020
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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