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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 K211148
Device Name CORE-Trocar
Applicant
Incore CO., LTD.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Applicant Contact Jae-Hun Lee
Correspondent
Incore CO., LTD.
11, Hyeoksin-daero, 78-gil, Dong-gu
Daegu,  KR 41072
Correspondent Contact Jae-Hun Lee
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/19/2021
Decision Date 06/21/2022
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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