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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K120127
Device Name SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
Applicant
SWAN VALLEY MEDICAL, INCORPORATED
16576 W. 53rd way
Golden,  CO  80403
Applicant Contact KEVIN RANDALL
Correspondent
SWAN VALLEY MEDICAL, INCORPORATED
16576 W. 53rd way
Golden,  CO  80403
Correspondent Contact KEVIN RANDALL
Regulation Number876.5090
Classification Product Code
KOB  
Subsequent Product Code
FEX  
Date Received01/17/2012
Decision Date 10/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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