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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 K121582
Device Name INVENDO C25 COLONOSCOPY SYSTEM
Applicant
Invendo Medical Gbmh
Peterhofstr. 3b
Kissing,  DE 86438
Applicant Contact OLIVER V RUEPPRECHT
Correspondent
Invendo Medical Gbmh
Peterhofstr. 3b
Kissing,  DE 86438
Correspondent Contact OLIVER V RUEPPRECHT
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/30/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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