0001213900-21-063320.txt : 20211203 0001213900-21-063320.hdr.sgml : 20211203 20211203160114 ACCESSION NUMBER: 0001213900-21-063320 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20211203 FILED AS OF DATE: 20211203 DATE AS OF CHANGE: 20211203 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IceCure Medical Ltd. CENTRAL INDEX KEY: 0001584371 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40753 FILM NUMBER: 211469924 BUSINESS ADDRESS: STREET 1: 7 HA'ESHEL ST., POB 3163 CITY: CAESAREA STATE: L3 ZIP: 38900 BUSINESS PHONE: 972-4-6230333 MAIL ADDRESS: STREET 1: 7 HA'ESHEL ST., POB 3163 CITY: CAESAREA STATE: L3 ZIP: 38900 6-K 1 ea151687-6k_icecuremedical.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of December 2021

 

Commission file number: 001-40753

 

ICECURE MEDICAL Ltd.

(Translation of registrant’s name into English)

 

7 Ha’Eshel St., PO Box 3163

Caesarea, 3079504 Israel

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒       Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____

 

 

 

 

 

 

CONTENTS

 

On November 24, 2021, IceCure Medical Ltd. (the “Company” or “IceCure”) submitted a pre-submission package to the U.S. Food and Drug Administration (the “FDA”) in which the Company proposed an intended use for early stage breast cancer and high risk to surgery for the Company’s IceCure family of systems and suggested a De Novo classification. Since the Company was previously granted Breakthrough Device Designation from the FDA for its ProSense system, this pre-submission package included a request for a sprint discussion under FDA procedures.

 

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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, thereunto duly authorized.

 

  IceCure Medical Ltd.
     
Date: December 3, 2021 By: /s/ Eyal Shamir
    Name:  Eyal Shamir
    Title: Chief Executive Officer

 

 

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