IceSense 3, ProSense, MultiSense

FDA 510(k) K183213 · IceCure Medical , Ltd.

Substantially Equivalent

510(k) numberK183213

Submission

Device name
IceSense 3, ProSense, MultiSense
Applicant
IceCure Medical , Ltd.
Caesarea, IL
Received
November 19, 2018
Decision date
December 20, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GEH – Unit, Cryosurgical, Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4350
Specialty
General, Plastic Surgery

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K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special Erbe Elektromedizin GmbH06/09/2026SE
K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional Erbe Elektromedizin GmbH04/22/2026SE
K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional Medical Brands Laboratories B.V.04/02/2026SE
K260377XSense Cryoablation System with CryoProbesGEH · Special IceCure Medical , Ltd.02/24/2026SE
K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional Medinice S.A.02/13/2026SE
K251524Dr. Yglo Skin Tag RemoverGEH · Traditional Theotclab Healthcare B.V.01/12/2026SE
K250742Focused Cryotherapy SystemGEH · Traditional Focused Cryo, Inc.12/09/2025SE
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More from Recensmedical, Inc.

510(k)DeviceDecision
K260377XSense Cryoablation System with CryoProbesGEH · Special 02/24/2026SE
K240892XSense Cryoablation System with CryoprobesGEH · Traditional 06/28/2024SE
K102360Icesence 3GEH · Traditional 11/29/2010SE

Questions and answers

When was IceSense 3, ProSense, MultiSense cleared by the FDA?

IceSense 3, ProSense, MultiSense (K183213) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 396 days after the submission was received.

What is the product code of K183213?

The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.