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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K244029
Device Name ROBOPERA (ER-R-002); ROBOPERA (ER-R-003)
Applicant
Endorobotics Co., Ltd.
3rd Floor, Dusan-Bears Tower
81, Wangsa-Ro, Dongdaemun-Gu
Seoul,  KR 02577
Applicant Contact Jihwan Kim
Correspondent
Global Medical Standard Consulting Co., Ltd.
66, Cheongcho-Ro, Deogyang-Gu, Goyang-Si
Gyeonggi-Do,  KR 10543
Correspondent Contact JongHyun Kim
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Codes
FDS   NAY  
Date Received12/30/2024
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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