Fuse Gastroscopy System

Gastroscope And Accessories, Flexible/rigid

ENDOCHOICE INC.

The following data is part of a premarket notification filed by Endochoice Inc. with the FDA for Fuse Gastroscopy System.

Pre-market Notification Details

Device IDK152182
510k NumberK152182
Device Name:Fuse Gastroscopy System
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant ENDOCHOICE INC. 11810 WILLS RD. Alpharetta,  GA  30009
ContactDaniel Hoefer
CorrespondentDaniel Hoefer
ENDOCHOICE INC. 11810 WILLS RD. Alpharetta,  GA  30009
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-05
Decision Date2015-12-10
Summary:summary

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