BONASTENT BILIARY

Stents, Drains And Dilators For The Biliary Ducts

ENDOCHOICE, INC.

The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Bonastent Biliary.

Pre-market Notification Details

Device IDK140760
510k NumberK140760
Device Name:BONASTENT BILIARY
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant ENDOCHOICE, INC. 1208-12 ROCKFORD RD. Toronto, On,  CA M2r 3a2
ContactBosmat Friedman
CorrespondentBosmat Friedman
ENDOCHOICE, INC. 1208-12 ROCKFORD RD. Toronto, On,  CA M2r 3a2
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-26
Decision Date2014-06-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08806369461528 K140760 000
08806369461160 K140760 000
08806369461184 K140760 000
08806369461207 K140760 000
08806369461221 K140760 000
08806369461245 K140760 000
08806369461429 K140760 000
08806369461443 K140760 000
08806369461467 K140760 000
08806369461481 K140760 000
08806369461504 K140760 000
08806369461146 K140760 000

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