Washington, DC 20549







Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

May 29, 2018

Date of Report (date of earliest event reported)



TransEnterix, Inc.

(Exact name of Registrant as specified in its charter)




Delaware   0-19437   11-2962080

(State or other jurisdiction of

incorporation or organization)



File Number)

  (I.R.S. Employer
Identification Number)

635 Davis Drive, Suite 300

Morrisville, North Carolina 27560

(Address of principal executive offices)


(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company    ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    ☐




Item 8.01 Other Items.

On May 29, 2018, TransEnterix, Inc. (the “Company”) announced that it has received U.S. Food and Drug Administration’s (“FDA”) 510(k) clearance for expanded indications for use of the Company’s Senhance™ Surgical System. The additional indications are for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery.


Item 9.01 Financial Statements and Exhibits

(d) Exhibits.


99.1    Press Release, issued May 29, 2018.


Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


      TransEnterix, Inc.
Date: May 29, 2018       /s/ Joseph P. Slattery

Joseph P. Slattery

EVP and Chief Financial Officer