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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K251170
Device Name Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
Applicant
Tangent Endoscopy, LLC
2140 Dupont Hwy.
Camden,  DE  19934
Applicant Contact Daniel Amendola
Correspondent
TAG3 Engineering
1161 Sawgrass Corporate Pkwy.
Sunrise,  FL  33323
Correspondent Contact Diane Horwitz
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
FET   NTN  
Date Received04/15/2025
Decision Date 09/12/2025
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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