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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 K253541
Device Name EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)
Applicant
Medical Impact
2314, 2214, 2217~2219, 122, Jomaru-Ro 385beon-Gil
Bucheon-Si
Gyeonggi-Do,  KR 14556
Applicant Contact Hanna Kim
Correspondent
Medical Impact
2314, 2214, 2217~2219, 122, Jomaru-Ro 385beon-Gil
Bucheon-Si
Gyeonggi-Do,  KR 14556
Correspondent Contact Hanna Kim
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
OCW  
Date Received11/14/2025
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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