Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008797959

FEI Number

3008797959

Entity Name

ICECURE MEDICAL LTD.

City/State/Country

Caesarea Northern, IL

Establishment Address

7 HaEshel street, POB 3163, Caesarea Northern 3079504, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IceCure Medical Ltd. (Owner Number: 10035292)

Owner / Operator Contact Address

7 HaEshel street, POB 3163, Caesarea, IL-Z 3079504, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183213

PMA Number

N/A

All Registered Proprietary Names

ProSense Cryoablation System ProSense Cryoablation System ProSense Cryoablation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-04-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2019-08-19
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-09-13

Official Correspondent

Maayan Levi

US Agent Details

Zvi Ladin Business: Boston MedTech Advisors Email: zladin@bmtadvisors.com Phone: (781) 4070900

Related Public Records

Same Entity

IceCure Medical Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

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3007335051	TURON MEDTECH AB	Varberg Halland, SE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008797959. Last updated year: 2026. Please use registration number 3008797959 when referencing this establishment in official correspondence.