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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, electrosurgical, active, urological
510(k) Number K120418
Models WA0014A, WA22602D, WA220603D, WA22606D, WA22607D, WA22632D,WA22621C, WA22623C, WA22651C,WA22655C, WA22657C
Device Name ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
Original Applicant
OLYMPUS WINTER & IBE GMBH
3500 corporate pkway
po box 610
center valley,  PA  18034 0610
Original Contact sheri musgnung
Regulation Number876.4300
Classification Product Code
FAS  
Subsequent Product Code
GEI  
Date Received02/10/2012
Decision Date 06/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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