Insufflation Retention Device

Colonoscope And Accessories, Flexible/rigid

Bpendo, LLC

The following data is part of a premarket notification filed by Bpendo, Llc with the FDA for Insufflation Retention Device.

Pre-market Notification Details

Device IDK213773
510k NumberK213773
Device Name:Insufflation Retention Device
ClassificationColonoscope And Accessories, Flexible/rigid
Applicant Bpendo, LLC 216 Foreman Circle Norman,  OK  73069
ContactRobert Holbrook
CorrespondentJames Fentress
Gilero, LLC 635 Davis Drive STE 100 Morrisville,  NC  27560
Product CodeFDF  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-02
Decision Date2022-07-21

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