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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 K222695
Device Name troCarWash™ System
Applicant
Biotex, Inc.
114 Holmes Rd.
Houston,  TX  77045
Applicant Contact Wade Munsch
Correspondent
Biotex, Inc.
114 Holmes Rd.
Houston,  TX  77045
Correspondent Contact Wade Munsch
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
FEQ  
Date Received09/06/2022
Decision Date 02/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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