Senhance Surgical Robotic 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 Robotic System.

Pre-market Notification Details

• Device ID: K171120
• 510k Number: K171120
• Device Name: Senhance Surgical Robotic System
• Classification: System, Surgical, Computer Controlled Instrument
• Applicant: TransEnterix, Inc. 635 Davis Drive, Suite 300 Morrisville, NC 27560
• Contact: Stephanie Fitts
• Correspondent: Stephanie Fitts; TransEnterix, Inc. 635 Davis Drive, Suite 300 Morrisville, NC 27560
• Product Code: NAY
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-14
• Decision Date: 2017-10-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815440022266	K171120	000
00815440020149	K171120	000
00815440020156	K171120	000
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00815440020507	K171120	000
00815440020514	K171120	000
00815440021108	K171120	000