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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 K233451
Device Name Arthrex Synergy Vision Endoscopic Imaging System
Applicant
Arthrex, Inc.
1370 Creekside Boulevard
Naples,  FL  34108
Applicant Contact Lai Saeteurn
Correspondent
Arthrex, Inc.
1370 Creekside Boulevard
Naples,  FL  34108
Correspondent Contact Lai Saeteurn
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
IZI  
Date Received10/20/2023
Decision Date 01/18/2024
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
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