UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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| Date of Report (Date of Earliest Event Reported): | | March 24, 2016 |
TransEnterix, Inc.
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(Exact name of registrant as specified in its charter)
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| Delaware | 0-19437 | 11-2962080 |
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(State or other jurisdiction | _____________
(Commission | ______________
(I.R.S. Employer |
| of incorporation) | File Number) | Identification No.) |
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| 635 Davis Drive, Suite 300, Morrisville, North Carolina | | 27560 |
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(Address of principal executive offices) | | ___________
(Zip Code) |
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| Registrant’s telephone number, including area code: | | 919-765-8400 |
Not Applicable
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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:
[ ] 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))
Item 8.01 Other Events.
On March 24, 2016, TransEnterix, Inc., a Delaware corporation (the "Company") announced that it has been in discussions with the U.S. Food and Drug Administration ("FDA") with respect to the Company’s pending 510(k) application for its SurgiBot™ System Robotic Platform System. The Company has updated its timing expectations and now expects to obtain a final determination from the FDA by mid-April 2016.
The Company’s press release is attached as Exhibit 99.1 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
Exhibit No. Description
99.1 Press release, dated March 24, 2016
SIGNATURES
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 hereunto duly authorized.
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| | | TransEnterix, Inc. |
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| March 24, 2016 | | By: | | /s/ Joseph P. Slattery
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| | | | | Name: Joseph P. Slattery |
| | | | | Title: EVP and CFO |
Exhibit Index
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| Exhibit No. | | Description |
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|
99.1 | | Press release, dated March 24, 2016 |
