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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K111480
Device Name MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
Applicant
Technology Delivery Systems, Inc.
1516 Thalia St.
New Orleans,  LA  70130
Applicant Contact JAMES HARVEY KNAUSS
Correspondent
Technology Delivery Systems, Inc.
1516 Thalia St.
New Orleans,  LA  70130
Correspondent Contact JAMES HARVEY KNAUSS
Regulation Number876.1500
Classification Product Code
FGB  
Date Received05/27/2011
Decision Date 04/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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