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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 K210710
FOIA Releasable 510(k) K210710
Device Name PENTAX Medical Video Duedenoscope ED34-i10T2
Applicant
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Applicant Contact William Goeller
Correspondent
Pentax of America, Inc.
3 Paragon Dr.,
Montvale,  NJ  07645
Correspondent Contact William Goeller
Regulation Number876.1500
Classification Product Code
FDT  
Date Received03/10/2021
Decision Date 04/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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