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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K132839
FOIA Releasable 510(k) K132839
Device Name FUSE 1C COLONOSCOPY SYSTEM
Applicant
Endochoice, Inc.
11810 Wills Rd.
Alpharetta,  GA  30009
Applicant Contact DANIEL HOEFER
Correspondent
Endochoice, Inc.
11810 Wills Rd.
Alpharetta,  GA  30009
Correspondent Contact DANIEL HOEFER
Regulation Number876.1500
Classification Product Code
FDF  
Date Received09/10/2013
Decision Date 02/06/2014
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
Predetermined Change
Control Plan Authorized		 No
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