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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K260573
Device Name EvoEndo Single-Use Endoscopy System
Applicant
EvoEndo, Inc.
888 E. Belvidere Rd.
Suite 212
Grayslake,  IL  60030
Applicant Contact Paul Imaoka
Correspondent
AlvaMed, Inc.
935 Great Plain Ave.
Unit 166
Needham,  MA  02492
Correspondent Contact Keira Jessop
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FET  
Date Received02/20/2026
Decision Date 04/21/2026
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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