Boa Endoscopic Valve

Endoscopic Irrigation/suction System

C2 THERAPEUTICS, INC.

The following data is part of a premarket notification filed by C2 Therapeutics, Inc. with the FDA for Boa Endoscopic Valve.

Pre-market Notification Details

Device IDK152140
510k NumberK152140
Device Name:Boa Endoscopic Valve
ClassificationEndoscopic Irrigation/suction System
Applicant C2 THERAPEUTICS, INC. 303 CONVENTION WAY, SUITE 1 Redwood City,  CA  94063
ContactTheresa Brandner-allen
CorrespondentTheresa Brandner-allen
C2 THERAPEUTICS, INC. 303 CONVENTION WAY, SUITE 1 Redwood City,  CA  94063
Product CodeOCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-03
Decision Date2015-10-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854924006163 K152140 000

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