SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER

Laparoscope, General & Plastic Surgery

TRANSENTERIX, INC.

The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Spider Flexible Blunt Dissector And Band Passer.

Pre-market Notification Details

Device IDK120403
510k NumberK120403
Device Name:SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER
ClassificationLaparoscope, General & Plastic Surgery
Applicant TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Durham,  NC  27560
ContactTammy B Carrea
CorrespondentTammy B Carrea
TRANSENTERIX, INC. 635 DAVIS DRIVE SUITE 300 Durham,  NC  27560
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-09
Decision Date2012-04-16
Summary:summary

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