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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystoscope And Accessories, Flexible/Rigid
510(k) Number K120766
FOIA Releasable 510(k) K120766
Device Name ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION)
Applicant
Prosurg, Inc.
2195 Trade Zone Blvd.
San Jose,  CA  95131
Applicant Contact A. DESAI
Correspondent
Prosurg, Inc.
2195 Trade Zone Blvd.
San Jose,  CA  95131
Correspondent Contact A. DESAI
Regulation Number876.1500
Classification Product Code
FAJ  
Date Received03/13/2012
Decision Date 09/11/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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