TransEnterix Senhance Surgical System

System, Surgical, Computer Controlled Instrument

TransEnterix, Inc.

The following data is part of a premarket notification filed by Transenterix, Inc. with the FDA for Transenterix Senhance Surgical System.

Pre-market Notification Details

Device IDK180163
510k NumberK180163
Device Name:TransEnterix Senhance Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant TransEnterix, Inc. 635 Davis Drive, Suite 300 Morrisville,  NC  27560
ContactStephanie Fitts
CorrespondentStephanie Fitts
TransEnterix, Inc. 635 Davis Drive, Suite 300 Morrisville,  NC  27560
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-19
Decision Date2018-05-25
Summary:summary

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