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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K002396
Device Name ENDOCARE PERCUTANEOUS ACCESS SET
Applicant
Endocare, Inc.
7 Studebaker
Irvine,  CA  92618
Applicant Contact VINCENT CUTARELLI
Correspondent
Endocare, Inc.
7 Studebaker
Irvine,  CA  92618
Correspondent Contact VINCENT CUTARELLI
Regulation Number876.5130
Classification Product Code
KOD  
Subsequent Product Code
GEH  
Date Received08/07/2000
Decision Date 10/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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