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FDA 510(k)

ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)

K-Number: K121507 · 2012-06-06

ApplicantAtriCure, Inc.
Decision Date2012-06-06
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2012-06-06 under 510(k) number K121507. 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 ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)?

ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) is a medical device that received FDA 510(k) clearance on 2012-06-06. The listed applicant is AtriCure, Inc.. The 510(k) number is K121507.

When did ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) receive FDA 510(k) clearance?

ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) received FDA 510(k) clearance on 2012-06-06, under 510(k) number K121507.

Who is the listed applicant for ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)?

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 ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)?

The FDA product code for ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) 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.

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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