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FDA 510(k)

ICESENCE 3

K-Number: K102360 · 2010-11-29

ApplicantIceCure Medical , Ltd.
Decision Date2010-11-29
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICESENCE 3 is the device name listed in this FDA 510(k) record. The listed applicant is IceCure Medical , Ltd.. It received FDA 510(k) clearance on 2010-11-29 under 510(k) number K102360. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICESENCE 3?

ICESENCE 3 is a medical device that received FDA 510(k) clearance on 2010-11-29. The listed applicant is IceCure Medical , Ltd.. The 510(k) number is K102360.

When did ICESENCE 3 receive FDA 510(k) clearance?

ICESENCE 3 received FDA 510(k) clearance on 2010-11-29, under 510(k) number K102360.

Who is the listed applicant for ICESENCE 3?

The FDA 510(k) record lists IceCure Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICESENCE 3?

The FDA product code for ICESENCE 3 is GEH.

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Other records listing IceCure Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260377XSense Cryoablation System with CryoProbesK240892XSense Cryoablation System with CryoprobesK183213IceSense 3, ProSense, MultiSense

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex MedicalK261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex MedicalK261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbHK253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbHK252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.K260377XSense Cryoablation System with CryoProbesIceCure Medical , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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