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 IDK192877
501k NumberK192877
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)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-08
Decision Date2019-11-22

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