Transenterix Inc

FDA Filings

This page includes the latest FDA filings for Transenterix Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

AMEX

TRXC

DUNS 969118900

Transenterix Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• TransEnterix Italia, S. r. L

FDA Registration(s)

• Registration Number: 3012880598
• FEI Number: 3012880598
• Name: TransEnterix Italia, S. r. L
• Owner & Operator: TransEnterix, Inc.
• Contact Address: 635 Davis Drive Suite 300; Morrisville NC 27560 US
• Official Correspondent:
  • Stephanie Fullard
  • x-919-7658000-x
• US Agent:
  • Stephanie Fullard
  • TRANSENTERIX, INC.
  • 919 7658422
  • 919 7658459
  • sfitts@transenterix.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Viale dell'Innovazione 3 ; Milano Lombardia, 20126 IT
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3007593944
• FEI Number: 3007593944
• Name: TransEnterix Surgical, Inc.
• Owner & Operator: TransEnterix, Inc.
• Contact Address: 635 Davis Drive Suite 300; Morrisville NC 27560 US
• Official Correspondent:
  • Stephanie Fullard
  • x-919-7658000-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 635 DAVIS DR STE 300 ; MORRISVILLE, NC 27560 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00815440022228 TRANSENTERIX, INC.	Senhance X9007741	2021-03-01
GUDID 00815440022082 TRANSENTERIX, INC.	Senhance	2020-08-13
GUDID 00815440022075 TRANSENTERIX, INC.	Senhance	2020-08-13
GUDID 00815440021931 TRANSENTERIX, INC.	Senhance	2020-08-13
PMN K200049 TransEnterix, Inc.	Senhance Surgical System	2020-03-09
GUDID 00815440021917 TRANSENTERIX, INC.	Senhance 210-11014	2019-12-05
GUDID 00815440021016 TRANSENTERIX, INC.	Senhance 210-21014	2019-12-05
PMN K192877 TransEnterix, Inc.	Senhance Surgical System	2019-11-22
GUDID 00815440021900 TRANSENTERIX, INC.	Senhance 210-11015	2019-08-09
GUDID 00815440021894 TRANSENTERIX, INC.	Senhance 210-11013	2019-08-09
GUDID 00815440021887 TRANSENTERIX, INC.	Senhance 210-11011	2019-08-09
GUDID 00815440021405 TRANSENTERIX, INC.	Senhance 210-21011	2019-08-09
GUDID 00815440021566 TRANSENTERIX, INC.	Senhance Ultrasonic 300-11010	2019-08-01
PMN K191482 TransEnterix Inc.	Senhance Surgical System	2019-07-11
GUDID 00815440021764 TRANSENTERIX, INC.	Senhance 500-21015	2019-03-07
GUDID 00815440021757 TRANSENTERIX, INC.	Senhance 500-21016	2019-03-07
GUDID 00815440021740 TRANSENTERIX, INC.	Senhance 500-21017	2019-03-07
GUDID 00815440021641 TRANSENTERIX, INC.	Senhance 220-11014	2019-03-07
GUDID 00815440021634 TRANSENTERIX, INC.	Senhance 220-11010	2019-03-07
GUDID 00815440021627 TRANSENTERIX, INC.	Senhance 220-11012	2019-03-07
GUDID 00815440021597 TRANSENTERIX, INC.	Senhance Ultrasonic 300-01012	2019-03-07
GUDID 00815440021580 TRANSENTERIX, INC.	Senhance Ultrasonic 300-01010	2019-03-07
GUDID 00815440021573 TRANSENTERIX, INC.	Senhance Ultrasonic 300-11011	2019-03-07
GUDID 00815440021450 TRANSENTERIX, INC.	Senhance 220-21010	2019-03-07
GUDID 00815440021443 TRANSENTERIX, INC.	Senhance 220-21012	2019-03-07
GUDID 00815440021122 TRANSENTERIX, INC.	Senhance Ultrasonic 300-21011	2019-03-07
PMN K182421 | NAY TransEnterix Surgical, Inc. [TransEnterix, Inc.]	Senhance Ultrasonic System	2019-01-18
PMN K182421 | NAY TransEnterix Italia, S. r. L [TransEnterix, Inc.]	Senhance Ultrasonic System	2019-01-18
PMN K182421 TransEnterix, Inc.	Senhance Ultrasonic System	2019-01-11
PMN K183098 TransEnterix, Inc.	Senhance Surgical System	2018-12-06
GUDID 00815440021696 TRANSENTERIX, INC.	Senhance 220-11031	2018-12-03
GUDID 00815440021689 TRANSENTERIX, INC.	Senhance 220-11029	2018-12-03
GUDID 00815440021672 TRANSENTERIX, INC.	Senhance 220-11025	2018-12-03
GUDID 00815440021665 TRANSENTERIX, INC.	Senhance 220-11027	2018-12-03
GUDID 00815440021658 TRANSENTERIX, INC.	Senhance 220-11033	2018-12-03
GUDID 00815440021498 TRANSENTERIX, INC.	Senhance 220-21031	2018-12-03
GUDID 00815440021481 TRANSENTERIX, INC.	Senhance 220-21029	2018-12-03
GUDID 00815440021474 TRANSENTERIX, INC.	Senhance 220-21025	2018-12-03
GUDID 00815440021467 TRANSENTERIX, INC.	Senhance 220-21027	2018-12-03
GUDID 00815440021429 TRANSENTERIX, INC.	Senhance 230-21018	2018-12-03
GUDID 00815440021412 TRANSENTERIX, INC.	Senhance 200-21096	2018-12-03
GUDID 00815440021399 TRANSENTERIX, INC.	Senhance 210-21046	2018-12-03
GUDID 00815440021382 TRANSENTERIX, INC.	Senhance 210-21044	2018-12-03
GUDID 00815440021375 TRANSENTERIX, INC.	Senhance 210-21042	2018-12-03
GUDID 00815440021368 TRANSENTERIX, INC.	Senhance 200-21094	2018-12-03
GUDID 00815440021351 TRANSENTERIX, INC.	Senhance 200-21092	2018-12-03
GUDID 00815440021344 TRANSENTERIX, INC.	Senhance 200-21090	2018-12-03
GUDID 00815440021337 TRANSENTERIX, INC.	Senhance 200-21088	2018-12-03
GUDID 00815440021320 TRANSENTERIX, INC.	Senhance 200-21086	2018-12-03
GUDID 00815440021313 TRANSENTERIX, INC.	Senhance 200-21082	2018-12-03
GUDID 00815440021306 TRANSENTERIX, INC.	Senhance 200-21080	2018-12-03
GUDID 00815440021283 TRANSENTERIX, INC.	Senhance 230-11018	2018-12-03
GUDID 00815440021276 TRANSENTERIX, INC.	Senhance 200-11096	2018-12-03
GUDID 00815440021252 TRANSENTERIX, INC.	Senhance 210-11046	2018-12-03
GUDID 00815440021245 TRANSENTERIX, INC.	Senhance	2018-12-03
GUDID 00815440021238 TRANSENTERIX, INC.	Senhance 210-11042	2018-12-03
GUDID 00815440021221 TRANSENTERIX, INC.	Senhance 200-11094	2018-12-03
GUDID 00815440021214 TRANSENTERIX, INC.	Senhance 200-11092	2018-12-03
GUDID 00815440021207 TRANSENTERIX, INC.	Senhance 200-11090	2018-12-03
GUDID 00815440021191 TRANSENTERIX, INC.	Senhance 200-11088	2018-12-03
GUDID 00815440021184 TRANSENTERIX, INC.	Senhance 200-11086	2018-12-03
GUDID 00815440021177 TRANSENTERIX, INC.	Senhance 200-11084	2018-12-03
GUDID 00815440021160 TRANSENTERIX, INC.	Senhance 200-21084	2018-12-03
GUDID 00815440021153 TRANSENTERIX, INC.	Senhance 200-11082	2018-12-03
GUDID 00815440021146 TRANSENTERIX, INC.	Senhance 200-11080	2018-12-03
GUDID 00815440020996 TRANSENTERIX, INC.	Senhance 200-21016	2018-12-03
GUDID 00815440020965 TRANSENTERIX, INC.	Senhance 210-21012	2018-12-03
GUDID 00815440020941 TRANSENTERIX, INC.	Senhance 210-21010	2018-12-03
GUDID 00815440020927 TRANSENTERIX, INC.	Senhance 200-21014	2018-12-03
GUDID 00815440020903 TRANSENTERIX, INC.	Senhance 200-21012	2018-12-03
GUDID 00815440020880 TRANSENTERIX, INC.	Senhance 200-21010	2018-12-03
GUDID 00815440020842 TRANSENTERIX, INC.	Senhance 220-21015	2018-12-03
GUDID 00815440020798 TRANSENTERIX, INC.	Senhance 220-11015	2018-12-03
GUDID 00815440020712 TRANSENTERIX, INC.	Senhance 200-11016	2018-12-03
GUDID 00815440020705 TRANSENTERIX, INC.	Senhance 210-11012	2018-12-03
GUDID 00815440020682 TRANSENTERIX, INC.	Senhance 210-11010	2018-12-03
GUDID 00815440020668 TRANSENTERIX, INC.	Senhance 200-11014	2018-12-03
GUDID 00815440020644 TRANSENTERIX, INC.	Senhance 200-11012	2018-12-03
GUDID 00815440020620 TRANSENTERIX, INC.	Senhance 200-11010	2018-12-03
GUDID 00815440020583 TRANSENTERIX, INC.	Senhance 230-21014	2018-12-03
GUDID 00815440020576 TRANSENTERIX, INC.	Senhance 230-21010	2018-12-03
GUDID 00815440020446 TRANSENTERIX, INC.	Senhance 200-21022	2018-12-03
GUDID 00815440020439 TRANSENTERIX, INC.	Senhance 200-21018	2018-12-03
GUDID 00815440020279 TRANSENTERIX, INC.	Senhance 230-11014	2018-12-03
GUDID 00815440020262 TRANSENTERIX, INC.	Senhance 230-11010	2018-12-03
GUDID 00815440020118 TRANSENTERIX, INC.	Senhance 200-11022	2018-12-03
GUDID 00815440020101 TRANSENTERIX, INC.	Senhance 200-11018	2018-12-03
PMN K181517 TransEnterix, Inc.	Senhance Surgical System	2018-10-09
GUDID 00815440020217 TRANSENTERIX, INC.	Senhance 210-11036	2018-07-06
GUDID 00815440020200 TRANSENTERIX, INC.	Senhance 210-11026	2018-07-06
GUDID 00815440020194 TRANSENTERIX, INC.	Senhance 210-11034	2018-07-06
GUDID 00815440020187 TRANSENTERIX, INC.	Senhance 210-11022	2018-07-06
GUDID 00815440020170 TRANSENTERIX, INC.	Senhance 210-11032	2018-07-06
GUDID 00815440020163 TRANSENTERIX, INC.	Senhance 210-11018	2018-07-06
GUDID 00815440020156 TRANSENTERIX, INC.	Senhance 200-11064	2018-07-06
GUDID 00815440020149 TRANSENTERIX, INC.	Senhance 200-11048	2018-07-06
GUDID 00815440020132 TRANSENTERIX, INC.	Senhance 200-11062	2018-07-06
GUDID 00815440020125 TRANSENTERIX, INC.	Senhance 200-11045	2018-07-06
GUDID 00815440020095 TRANSENTERIX, INC.	Senhance 200-11060	2018-07-06
GUDID 00815440020088 TRANSENTERIX, INC.	Senhance 200-11042	2018-07-06
GUDID 00815440020071 TRANSENTERIX, INC.	Senhance 200-11058	2018-07-06
GUDID 00815440020064 TRANSENTERIX, INC.	Senhance 200-11038	2018-07-06
GUDID 00815440020057 TRANSENTERIX, INC.	Senhance 200-11056	2018-07-06
GUDID 00815440020040 TRANSENTERIX, INC.	Senhance 200-11034	2018-07-06
GUDID 00815440020033 TRANSENTERIX, INC.	Senhance 200-11054	2018-07-06
GUDID 00815440020026 TRANSENTERIX, INC.	Senhance 200-11030	2018-07-06
GUDID 00815440020019 TRANSENTERIX, INC.	Senhance 200-11052	2018-07-06
GUDID 00815440020002 TRANSENTERIX, INC.	Senhance 200-11026	2018-07-06
PMN K180163 TransEnterix, Inc.	TransEnterix Senhance Surgical System	2018-05-25
PMN K171120 | NAY TransEnterix Surgical, Inc. [TransEnterix, Inc.]	Senhance Surgical System	2017-11-06
PMN K171120 | NAY TransEnterix Italia, S. r. L [TransEnterix, Inc.]	Senhance Surgical System	2017-11-06
PMN K171120 | GCJ TransEnterix Surgical, Inc. [TransEnterix, Inc.]	Senhance Surgical System	2017-11-06
PMN K171120 | GCJ TransEnterix Italia, S. r. L [TransEnterix, Inc.]	Senhance Surgical System	2017-11-06
PMN K171120 TransEnterix, Inc.	Senhance Surgical Robotic System	2017-10-13
PMN K122299 TRANSENTERIX, INC.	SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR	2012-10-25
PMN K120403 TRANSENTERIX, INC.	SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER	2012-04-16
PMN K102839 TRANSENTERIX, INC.	SPIDER STANDARD AND ADVANCED	2011-03-15
PMN K102646 TRANSENTERIX, INC.	SPIDER FLEX MONOPOLAR HOOK	2010-11-03
PMN K091697 TRANSENTERIX, INC.	SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015	2009-09-28
PMN K090902 TRANSENTERIX, INC.	SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003	2009-07-22

Related Finance Registrations

NCAGE Code	61YA9	TRANSENTERIX INC.
CAGE Code	61YA9	TRANSENTERIX INC.
DUNS	831534560	TRANSENTERIX INC.
SEC	0000876378	TRANSENTERIX, INC. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019021660053	Algeciras,Spain -> Charleston, South Carolina	MEDICAL EQUIPMENT	19 BOX
2019021660058	Algeciras,Spain -> Charleston, South Carolina	MEDICAL EQUIPMENT	1 BOX
2019021152772	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT	12 PKG
2019020975722	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	MEDICAL EQUIPMENT	12 PKG