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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 K242699
Device Name Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
Applicant
Opcom Medical, Inc.
12f, #6, Jiankang Rd., Zhonghe Dist.
New Taipei City,  TW 23586
Applicant Contact ChingLin Huang
Correspondent
Opcom Medical, Inc.
12f, #6, Jiankang Rd., Zhonghe Dist.
New Taipei City,  TW 23586
Correspondent Contact ChingLin Huang
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Code
FET  
Date Received09/09/2024
Decision Date 05/28/2025
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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