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FDA 510(k)

VISUAL-ICE CRYOABLATION SYSTEM

K-Number: K123865 · 2013-02-06

ApplicantGalil Medical, Inc.
Decision Date2013-02-06
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VISUAL-ICE CRYOABLATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Galil Medical, Inc.. It received FDA 510(k) clearance on 2013-02-06 under 510(k) number K123865. 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 VISUAL-ICE CRYOABLATION SYSTEM?

VISUAL-ICE CRYOABLATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Galil Medical, Inc.. The 510(k) number is K123865.

When did VISUAL-ICE CRYOABLATION SYSTEM receive FDA 510(k) clearance?

VISUAL-ICE CRYOABLATION SYSTEM received FDA 510(k) clearance on 2013-02-06, under 510(k) number K123865.

Who is the listed applicant for VISUAL-ICE CRYOABLATION SYSTEM?

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

What is the FDA product code for VISUAL-ICE CRYOABLATION SYSTEM?

The FDA product code for VISUAL-ICE CRYOABLATION SYSTEM is GEH.

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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

View on FDA Database →

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

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