Pentax Medical Video Duodenoscope ED34-i10T2

Duodenoscope And Accessories, Flexible/rigid

PENTAX Of America, Inc.

The following data is part of a premarket notification filed by Pentax Of America, Inc. with the FDA for Pentax Medical Video Duodenoscope Ed34-i10t2.

Pre-market Notification Details

Device IDK192245
501k NumberK192245
Device Name:Pentax Medical Video Duodenoscope ED34-i10T2
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
ContactWilliam Goeller
CorrespondentWilliam Goeller
PENTAX Of America, Inc. 3 Paragon Drive Montvale,  NJ  07645 -1782
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-19
Decision Date2019-11-15

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