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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, general & plastic surgery
510(k) Number K122511
Models 2B12LT, 2B12XT, 2CB12LT, 2D12LT, 2D12XT, 2H12LP
Device Name ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH
Original Applicant
ETHICON ENDO-SURGERY, LLC
4545 creek road
cincinnati,  OH  45242
Original Contact emily kruetzkamp
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/17/2012
Decision Date 10/01/2012
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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