0001193125-15-000948.txt : 20150105 0001193125-15-000948.hdr.sgml : 20150105 20150105064200 ACCESSION NUMBER: 0001193125-15-000948 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20141218 ITEM INFORMATION: Other Events FILED AS OF DATE: 20150105 DATE AS OF CHANGE: 20150105 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Stereotaxis, Inc. CENTRAL INDEX KEY: 0001289340 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 943120386 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36159 FILM NUMBER: 15502482 BUSINESS ADDRESS: STREET 1: 4320 FOREST PARK AVENUE STREET 2: SUITE 100 CITY: ST.LOUIS STATE: MO ZIP: 63108 BUSINESS PHONE: 314-678-6100 MAIL ADDRESS: STREET 1: 4320 FOREST PARK AVENUE STREET 2: SUITE 100 CITY: ST.LOUIS STATE: MO ZIP: 63108 8-K 1 d844991d8k.htm 8-K 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of report (Date of earliest event reported): December 18, 2014

 

 

STEREOTAXIS, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

 

 

Delaware   001-36159   94-3120386

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

4320 Forest Park Avenue, Suite 100, St. Louis, Missouri   63108
(Address of Principal Executive Offices)   (Zip Code)

(314) 678-6100

(Registrant’s Telephone Number, Including Area Code)

(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))

 

 

 


Item 8.01. Other Events

Stereotaxis, Inc. (the “Company”) was granted 510(k) clearance by the Food and Drug Administration on December 18, 2014, to market its Vdrive® with V-CAS™ Catheter Advancement System in the U.S. The Company also has received regulatory approval of its Odyssey® system by the Japan Pharmaceuticals and Medical Devices Agency.


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.

 

      STEREOTAXIS, INC.
Date: January 5, 2015     By:  

/s/ Karen Witte Duros

    Name:   Karen Witte Duros
    Title:   Sr. Vice President, General Counsel