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 Senhance Surgical System.

Pre-market Notification Details

Device IDK191482
510k NumberK191482
Device Name:Senhance Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant TransEnterix Inc. 635 Davis Drive, Suite 300 Morrisville,  NC  27560
ContactKaitlyn Alexander
CorrespondentKaitlyn Alexander
TransEnterix Inc. 635 Davis Drive, Suite 300 Morrisville,  NC  27560
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-04
Decision Date2019-07-11

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