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.

USAAMEXTRXCDUNS 969118900

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

FDA Registration(s)
Registration Number3012880598
FEI Number3012880598
NameTransEnterix Italia, S. r. L
Owner & OperatorTransEnterix, Inc.
Contact Address635 Davis Drive Suite 300
Morrisville NC 27560 US
Official Correspondent
  • Stephanie Fullard
  • x-919-7658000-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressViale dell'Innovazione 3
Milano Lombardia, 20126 IT
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3007593944
FEI Number3007593944
NameTransEnterix Surgical, Inc.
Owner & OperatorTransEnterix, Inc.
Contact Address635 Davis Drive Suite 300
Morrisville NC 27560 US
Official Correspondent
  • Stephanie Fullard
  • x-919-7658000-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address635 DAVIS DR STE 300
MORRISVILLE, NC 27560 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
TRANSENTERIX, INC.
Senhance X90077412021-03-01
TRANSENTERIX, INC.
Senhance 2020-08-13
TRANSENTERIX, INC.
Senhance 2020-08-13
TRANSENTERIX, INC.
Senhance 2020-08-13
TransEnterix, Inc.
Senhance Surgical System2020-03-09
TRANSENTERIX, INC.
Senhance 210-110142019-12-05
TRANSENTERIX, INC.
Senhance 210-210142019-12-05
TransEnterix, Inc.
Senhance Surgical System2019-11-22
TRANSENTERIX, INC.
Senhance 210-110152019-08-09
TRANSENTERIX, INC.
Senhance 210-110132019-08-09
TRANSENTERIX, INC.
Senhance 210-110112019-08-09
TRANSENTERIX, INC.
Senhance 210-210112019-08-09
TRANSENTERIX, INC.
Senhance Ultrasonic 300-110102019-08-01
TransEnterix Inc.
Senhance Surgical System2019-07-11
TRANSENTERIX, INC.
Senhance 500-210152019-03-07
TRANSENTERIX, INC.
Senhance 500-210162019-03-07
TRANSENTERIX, INC.
Senhance 500-210172019-03-07
TRANSENTERIX, INC.
Senhance 220-110142019-03-07
TRANSENTERIX, INC.
Senhance 220-110102019-03-07
TRANSENTERIX, INC.
Senhance 220-110122019-03-07
TRANSENTERIX, INC.
Senhance Ultrasonic 300-010122019-03-07
TRANSENTERIX, INC.
Senhance Ultrasonic 300-010102019-03-07
TRANSENTERIX, INC.
Senhance Ultrasonic 300-110112019-03-07
TRANSENTERIX, INC.
Senhance 220-210102019-03-07
TRANSENTERIX, INC.
Senhance 220-210122019-03-07
TRANSENTERIX, INC.
Senhance Ultrasonic 300-210112019-03-07
TransEnterix Surgical, Inc. [TransEnterix, Inc.]
Senhance Ultrasonic System2019-01-18
TransEnterix Italia, S. r. L [TransEnterix, Inc.]
Senhance Ultrasonic System2019-01-18
TransEnterix, Inc.
Senhance Ultrasonic System2019-01-11
TransEnterix, Inc.
Senhance Surgical System2018-12-06
TRANSENTERIX, INC.
Senhance 220-110312018-12-03
TRANSENTERIX, INC.
Senhance 220-110292018-12-03
TRANSENTERIX, INC.
Senhance 220-110252018-12-03
TRANSENTERIX, INC.
Senhance 220-110272018-12-03
TRANSENTERIX, INC.
Senhance 220-110332018-12-03
TRANSENTERIX, INC.
Senhance 220-210312018-12-03
TRANSENTERIX, INC.
Senhance 220-210292018-12-03
TRANSENTERIX, INC.
Senhance 220-210252018-12-03
TRANSENTERIX, INC.
Senhance 220-210272018-12-03
TRANSENTERIX, INC.
Senhance 230-210182018-12-03
TRANSENTERIX, INC.
Senhance 200-210962018-12-03
TRANSENTERIX, INC.
Senhance 210-210462018-12-03
TRANSENTERIX, INC.
Senhance 210-210442018-12-03
TRANSENTERIX, INC.
Senhance 210-210422018-12-03
TRANSENTERIX, INC.
Senhance 200-210942018-12-03
TRANSENTERIX, INC.
Senhance 200-210922018-12-03
TRANSENTERIX, INC.
Senhance 200-210902018-12-03
TRANSENTERIX, INC.
Senhance 200-210882018-12-03
TRANSENTERIX, INC.
Senhance 200-210862018-12-03
TRANSENTERIX, INC.
Senhance 200-210822018-12-03
TRANSENTERIX, INC.
Senhance 200-210802018-12-03
TRANSENTERIX, INC.
Senhance 230-110182018-12-03
TRANSENTERIX, INC.
Senhance 200-110962018-12-03
TRANSENTERIX, INC.
Senhance 210-110462018-12-03
TRANSENTERIX, INC.
Senhance 2018-12-03
TRANSENTERIX, INC.
Senhance 210-110422018-12-03
TRANSENTERIX, INC.
Senhance 200-110942018-12-03
TRANSENTERIX, INC.
Senhance 200-110922018-12-03
TRANSENTERIX, INC.
Senhance 200-110902018-12-03
TRANSENTERIX, INC.
Senhance 200-110882018-12-03
TRANSENTERIX, INC.
Senhance 200-110862018-12-03
TRANSENTERIX, INC.
Senhance 200-110842018-12-03
TRANSENTERIX, INC.
Senhance 200-210842018-12-03
TRANSENTERIX, INC.
Senhance 200-110822018-12-03
TRANSENTERIX, INC.
Senhance 200-110802018-12-03
TRANSENTERIX, INC.
Senhance 200-210162018-12-03
TRANSENTERIX, INC.
Senhance 210-210122018-12-03
TRANSENTERIX, INC.
Senhance 210-210102018-12-03
TRANSENTERIX, INC.
Senhance 200-210142018-12-03
TRANSENTERIX, INC.
Senhance 200-210122018-12-03
TRANSENTERIX, INC.
Senhance 200-210102018-12-03
TRANSENTERIX, INC.
Senhance 220-210152018-12-03
TRANSENTERIX, INC.
Senhance 220-110152018-12-03
TRANSENTERIX, INC.
Senhance 200-110162018-12-03
TRANSENTERIX, INC.
Senhance 210-110122018-12-03
TRANSENTERIX, INC.
Senhance 210-110102018-12-03
TRANSENTERIX, INC.
Senhance 200-110142018-12-03
TRANSENTERIX, INC.
Senhance 200-110122018-12-03
TRANSENTERIX, INC.
Senhance 200-110102018-12-03
TRANSENTERIX, INC.
Senhance 230-210142018-12-03
TRANSENTERIX, INC.
Senhance 230-210102018-12-03
TRANSENTERIX, INC.
Senhance 200-210222018-12-03
TRANSENTERIX, INC.
Senhance 200-210182018-12-03
TRANSENTERIX, INC.
Senhance 230-110142018-12-03
TRANSENTERIX, INC.
Senhance 230-110102018-12-03
TRANSENTERIX, INC.
Senhance 200-110222018-12-03
TRANSENTERIX, INC.
Senhance 200-110182018-12-03
TransEnterix, Inc.
Senhance Surgical System2018-10-09
TRANSENTERIX, INC.
Senhance 210-110362018-07-06
TRANSENTERIX, INC.
Senhance 210-110262018-07-06
TRANSENTERIX, INC.
Senhance 210-110342018-07-06
TRANSENTERIX, INC.
Senhance 210-110222018-07-06
TRANSENTERIX, INC.
Senhance 210-110322018-07-06
TRANSENTERIX, INC.
Senhance 210-110182018-07-06
TRANSENTERIX, INC.
Senhance 200-110642018-07-06
TRANSENTERIX, INC.
Senhance 200-110482018-07-06
TRANSENTERIX, INC.
Senhance 200-110622018-07-06
TRANSENTERIX, INC.
Senhance 200-110452018-07-06
TRANSENTERIX, INC.
Senhance 200-110602018-07-06
TRANSENTERIX, INC.
Senhance 200-110422018-07-06
TRANSENTERIX, INC.
Senhance 200-110582018-07-06
TRANSENTERIX, INC.
Senhance 200-110382018-07-06
TRANSENTERIX, INC.
Senhance 200-110562018-07-06
TRANSENTERIX, INC.
Senhance 200-110342018-07-06
TRANSENTERIX, INC.
Senhance 200-110542018-07-06
TRANSENTERIX, INC.
Senhance 200-110302018-07-06
TRANSENTERIX, INC.
Senhance 200-110522018-07-06
TRANSENTERIX, INC.
Senhance 200-110262018-07-06
TransEnterix, Inc.
TransEnterix Senhance Surgical System2018-05-25
TransEnterix Surgical, Inc. [TransEnterix, Inc.]
Senhance Surgical System2017-11-06
TransEnterix Italia, S. r. L [TransEnterix, Inc.]
Senhance Surgical System2017-11-06
TransEnterix Surgical, Inc. [TransEnterix, Inc.]
Senhance Surgical System2017-11-06
TransEnterix Italia, S. r. L [TransEnterix, Inc.]
Senhance Surgical System2017-11-06
TransEnterix, Inc.
Senhance Surgical Robotic System2017-10-13
TRANSENTERIX, INC.
SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR2012-10-25
TRANSENTERIX, INC.
SPIDER FLEXIBLE BLUNT DISSECTOR AND BAND PASSER2012-04-16
TRANSENTERIX, INC.
SPIDER STANDARD AND ADVANCED2011-03-15
TRANSENTERIX, INC.
SPIDER FLEX MONOPOLAR HOOK2010-11-03
TRANSENTERIX, INC.
SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 900152009-09-28
TRANSENTERIX, INC.
SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 900032009-07-22

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019021660053Algeciras,Spain -> Charleston, South CarolinaMEDICAL EQUIPMENT19 BOX
2019021660058Algeciras,Spain -> Charleston, South CarolinaMEDICAL EQUIPMENT1 BOX
2019021152772Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT12 PKG
2019020975722Stadersand,Federal Republic of Germany -> Charleston, South CarolinaMEDICAL EQUIPMENT12 PKG

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.