Transenterix Surgical Inc

FDA Filings

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

FDA Registration(s)

• 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
PMN K182421 | NAY TransEnterix Surgical, Inc. [TransEnterix, Inc.]	Senhance Ultrasonic System	2019-01-18
PMN K171120 | NAY TransEnterix Surgical, Inc. [TransEnterix, Inc.]	Senhance Surgical System	2017-11-06
PMN K171120 | GCJ TransEnterix Surgical, Inc. [TransEnterix, Inc.]	Senhance Surgical System	2017-11-06

Related Finance Registrations

SEC

0001423503

TRANSENTERIX SURGICAL INC of DELAWARE