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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K202365
Device Name Pentax Medical Video Duodenoscope ED32-i10
Applicant
Pentax of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Applicant Contact William Goeller
Correspondent
Pentax of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Correspondent Contact William Goeller
Regulation Number876.1500
Classification Product Code
FDT  
Date Received08/19/2020
Decision Date 04/01/2021
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
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