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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 K181084
Device Name PENTAX Video Colonoscopes (EC Family)
Applicant
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Applicant Contact James W. Monroe
Correspondent
PENTAX of America, Inc.
3 Paragon Drive
Montvale,  NJ  07645 -1782
Correspondent Contact James W. Monroe
Regulation Number876.1500
Classification Product Code
FDF  
Date Received04/24/2018
Decision Date 01/18/2019
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
Recalls CDRH Recalls
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