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FDA 510(k)

cryoFORM cryoICE cryoablation probe

K-Number: K152337 · 2016-03-22

ApplicantAtriCure, Inc.
Decision Date2016-03-22
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

cryoFORM cryoICE cryoablation probe is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K152337. 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 cryoFORM cryoICE cryoablation probe?

cryoFORM cryoICE cryoablation probe is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is AtriCure, Inc.. The 510(k) number is K152337.

When did cryoFORM cryoICE cryoablation probe receive FDA 510(k) clearance?

cryoFORM cryoICE cryoablation probe received FDA 510(k) clearance on 2016-03-22, under 510(k) number K152337.

Who is the listed applicant for cryoFORM cryoICE cryoablation probe?

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

What is the FDA product code for cryoFORM cryoICE cryoablation probe?

The FDA product code for cryoFORM cryoICE cryoablation probe is GEH.

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Other records listing AtriCure, Inc. as applicant

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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.

K261068Maverix 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.K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)Medinice S.A.

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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