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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 Im
Saneso Inc.
One Oxford Center, 301 Grant Street Suite 4300
Pittsburgh,  PA  15219
Applicant Contact Nitesh Ratnakar
Elexes Medical Consulting, LLC
30 N Gould St Ste R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Regulation Number876.1500
Classification Product Code
Subsequent Product Codes
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