Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ATRICURE CRYO MODULE SYSTEM

K-Number: K112072 · 2011-08-03

ApplicantAtriCure, Inc.
Decision Date2011-08-03
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRICURE CRYO MODULE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2011-08-03 under 510(k) number K112072. 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?

ATRICURE CRYO MODULE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-03. The listed applicant is AtriCure, Inc.. The 510(k) number is K112072.

When did ATRICURE CRYO MODULE SYSTEM receive FDA 510(k) clearance?

ATRICURE CRYO MODULE SYSTEM received FDA 510(k) clearance on 2011-08-03, under 510(k) number K112072.

Who is the listed applicant for ATRICURE CRYO MODULE SYSTEM?

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?

The FDA product code for ATRICURE CRYO MODULE SYSTEM is GEH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing AtriCure, Inc. 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.

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)K250371cryoICE cryoXT cryoablation probe (cryoXT)K243860AtriClip PRO-Mini LAA Exclusion System (PROM)K243157AtriCure cryoICE BOX (ACM)K234151Isolator Synergy EnCapture Ablation System (EMH)K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)

View all 54 devices →

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.

↑