Cryo-Touch III
FDA 510(k) K120415 · Myoscience, Inc.
510(k) numberK120415
Submission
- Device name
- Cryo-Touch III
- Applicant
- Myoscience, Inc.
Redwood City, CA, US - Received
- February 10, 2012
- Decision date
- June 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243677 | iovera° SystemGXH · Special | Pacira Biosciences, Inc. | 12/26/2024SE |
| K243157 | AtriCure cryoICE BOX (ACM)GXH · Special | AtriCure, Inc. | 10/29/2024SE |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe…GXH · Special | AtriCure, Inc. | 10/26/2023SE |
| K220656 | iovera SystemGXH · Special | Pacira Biosciences, Inc. | 05/20/2022SE |
| K211334 | Iovera SystemGXH · Special | Pacira Pharmaceuticals, Inc. | 09/10/2021SE |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…GXH · Traditional | AtriCure, Inc. | 12/23/2020SE |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probeGXH · Special | AtriCure, Inc. | 11/09/2018SE |
| K173763 | iovera systemGXH · Traditional | Myoscience, Inc. | 02/28/2018SE |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2)GXH · Special | AtriCure, Inc. | 02/15/2018SE |
More from AtriCure, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173763 | iovera systemGXH · Traditional | 02/28/2018SE |
| K161835 | iovera systemGXH · Traditional | 03/24/2017SE |
| K142866 | Myoscience iovera systemGXH · Traditional | 01/21/2015SE |
| K133453 | IoveraGXH · Traditional | 03/24/2014SE |
| K123516 | Cryo-Touch IVGXH · Traditional | 01/10/2013SE |
| K102021 | Cryo-Touch IIGXH · Special | 09/17/2010SE |
| K100447 | Myoscience Cryo-TouchGXH · Traditional | 06/25/2010SE |
| K083493 | Myoscience Cryo-TouchGEH · Traditional | 03/20/2009SE |
Questions and answers
When was Cryo-Touch III cleared by the FDA?
Cryo-Touch III (K120415) received a 510(k) decision of Substantially Equivalent on June 22, 2012, 133 days after the submission was received.
What is the product code of K120415?
The FDA product code is GXH – Device, Surgical, Cryogenic, a Class II (moderate risk) device regulated under 21 CFR 882.4250.