ENDOCHOICE HOT BIOPSY FORCEPS

Forceps, Biopsy, Electric

ENDOCHOICE, INC.

The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Endochoice Hot Biopsy Forceps.

Pre-market Notification Details

Device IDK131991
510k NumberK131991
Device Name:ENDOCHOICE HOT BIOPSY FORCEPS
ClassificationForceps, Biopsy, Electric
Applicant ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta,  GA  30009
ContactDaniel Hoefer
CorrespondentDaniel Hoefer
ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta,  GA  30009
Product CodeKGE  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-28
Decision Date2013-10-15
Summary:summary

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