Devices · TransEnterix, Inc.

TransEnterix Senhance Surgical System

TransEnterix, Inc. is listed for TransEnterix Senhance Surgical System (K180163). The FDA list gives May 25, 2018 as the date of the final decision. The lead panel is Gastroenterology-Urology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code NAY as “System, Surgical, Computer Controlled Instrument”: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K180163

Official FDA database record

Date of final decision

May 25, 2018

Company on the FDA list

TransEnterix, Inc.

Lead panel

Gastroenterology-Urology

Primary product code

NAY

openFDA device name for the code

System, Surgical, Computer Controlled Instrument

Device class

2

Regulation number

876.1500

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary