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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K112318
Device Name CLEARPATH 24
Applicant
Promedic, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Promedic, Inc.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.1500
Classification Product Code
OCX  
Date Received08/11/2011
Decision Date 06/29/2012
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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