# Atricure Cryo Module System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/atricure-cryo-module-system-geh>
- Manufacturer: [Atricure, Inc.](https://devicerts.com/manufacturers/atricure-inc) (United States)
- Name in the registry: ATRICURE CRYO MODULE SYSTEM
- Device class: Class II (US FDA)
- FDA product code: GEH

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K140058 · decision 2014-01-24 · decision SESE · status: Active

## Recalls

- Z-0927-2024 · Class II · ongoing · initiated 2023-11-28: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
- Z-0928-2024 · Class II · ongoing · initiated 2023-11-28: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.

## Identifiers

- 510(k) Number: K140058 [FDA 510(k)]
- FDA product code: GEH [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 878.4350 [FDA 510(k)]
- Advisory committee: General, Plastic Surgery [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: Atricure Cryo Module System, Atricure, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/atricure-cryo-module-system-geh (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/atricure-cryo-module-system-geh.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/atricure-cryo-module-system-geh
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.