Senhance Ultrasonic 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 Ultrasonic System.

Pre-market Notification Details

Device IDK182421
510k NumberK182421
Device Name:Senhance Ultrasonic System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville,  NC  27650
ContactStephanie M. Fitts
CorrespondentStephanie M. Fitts
TransEnterix, Inc. 635 Davis Drive Suite 300 Morrisville,  NC  27650
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-05
Decision Date2019-01-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815440021597 K182421 000
00815440021580 K182421 000
00815440021573 K182421 000
00815440021566 K182421 000
00815440021122 K182421 000

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