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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(K) Number K121510
Device Name IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE
60 middletown ave
north haven,  CT  06473
Contact sarah rizk
Regulation Number878.4750
Classification Product Code
GDW  
Date Received05/21/2012
Decision Date 07/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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