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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K002583
Device Name TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
Applicant
Vidamed, Inc.
46107 Landing Pkwy.
Fremont,  CA  94538
Applicant Contact TOM MCGAFFIGAN
Correspondent
Vidamed, Inc.
46107 Landing Pkwy.
Fremont,  CA  94538
Correspondent Contact TOM MCGAFFIGAN
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Code
GEI  
Date Received08/18/2000
Decision Date 02/13/2001
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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