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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K150083
Device Name Sidecar External Working Channel
Applicant
C2 THERAPEUTICS
303 CONVENTION WAY
SUITE 1
REDWOOD CITY,  CA  94063
Applicant Contact THERESA BRANDNER-ALLEN
Correspondent
C2 THERAPEUTICS
303 CONVENTION WAY
SUITE 1
REDWOOD CITY,  CA  94063
Correspondent Contact THERESA BRANDNER-ALLEN
Regulation Number876.1500
Classification Product Code
FED  
Date Received01/15/2015
Decision Date 04/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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