SEAL BIOPSY VALVE - REUSABLE

Endoscopic Irrigation/suction System

ENDOCHOICE, INC.

The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Seal Biopsy Valve - Reusable.

Pre-market Notification Details

Device IDK132776
510k NumberK132776
Device Name:SEAL BIOPSY VALVE - REUSABLE
ClassificationEndoscopic Irrigation/suction System
Applicant ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta,  GA  30009
ContactDaniel Hoefer
CorrespondentDaniel Hoefer
ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta,  GA  30009
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-05
Decision Date2013-12-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.