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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 K213606
Device Name EvoEndo Single-Use Endoscopy System
Applicant
EvoEndo, Inc.
12649 E. Caley Ave., Suite 116
Centennial,  CO  80111
Applicant Contact Heather Underwood
Correspondent
Proxima Clinical Research
2450 Holcombe Blvd.
Houston,  TX  77021
Correspondent Contact Isabella Schmitt
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FET  
Date Received11/15/2021
Decision Date 02/14/2022
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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