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
00815440021924	K171120	000
00815440020156	K171120	000
00815440020163	K171120	000
00815440020170	K171120	000
00815440020187	K171120	000
00815440020194	K171120	000
00815440020200	K171120	000
00815440020217	K171120	000
00815440020224	K171120	000
00815440020231	K171120	000
00815440020248	K171120	000
00815440020255	K171120	000
00815440020286	K171120	000
00815440020316	K171120	000
00815440020323	K171120	000
00815440020330	K171120	000
00815440020149	K171120	000
00815440020132	K171120	000
00815440022280	K171120	000
00815440021740	K171120	000
00815440021757	K171120	000
00815440021764	K171120	000
00815440020002	K171120	000
00815440020019	K171120	000
00815440020026	K171120	000
00815440020033	K171120	000
00815440020040	K171120	000
00815440020057	K171120	000
00815440020064	K171120	000
00815440020071	K171120	000
00815440020088	K171120	000
00815440020095	K171120	000
00815440020125	K171120	000
00815440020347	K171120	000
00815440020354	K171120	000
00815440020552	K171120	000
00815440020569	K171120	000
00815440020590	K171120	000
00815440020606	K171120	000
00815440020781	K171120	000
00815440020804	K171120	000
00815440020811	K171120	000
00815440020828	K171120	000
00815440020835	K171120	000
00815440020859	K171120	000
00815440020866	K171120	000
00815440021061	K171120	000
00815440021078	K171120	000
00815440021085	K171120	000
00815440021092	K171120	000
00815440020545	K171120	000
00815440020538	K171120	000
00815440020361	K171120	000
00815440020378	K171120	000
00815440020385	K171120	000
00815440020392	K171120	000
00815440020408	K171120	000
00815440020415	K171120	000
00815440020422	K171120	000
00815440020453	K171120	000
00815440020460	K171120	000
00815440020477	K171120	000
00815440020484	K171120	000
00815440020491	K171120	000
00815440020507	K171120	000
00815440020514	K171120	000
00815440020521	K171120	000
00815440021108	K171120	000