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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K210052
Device Name Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
Applicant
Saneso, Inc.
One Oxford Center, 301 Grant St.
Suite 4300
Pittsburgh,  PA  15219
Applicant Contact Nitesh Ratnakar
Correspondent
Elexes Medical Consulting, LLC
30 N Gould St., Suite R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Codes
FDS   FET   NWB  
Date Received01/08/2021
Decision Date 04/01/2022
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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