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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K253505
Device Name Zamenix™ P
Applicant
Roen Surgical, Inc.
193, Munji-Ro, Yuseong-Gu
T122, Truth Hall
Daejeon,  KR 34051
Applicant Contact Dayoung Kim
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number876.1500
Classification Product Code
FGB  
Date Received10/31/2025
Decision Date 08/07/2026
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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