iovera system
FDA 510(k) K161835 · Myoscience, Inc.
510(k) numberK161835
Submission
- Device name
- iovera system
- Applicant
- Myoscience, Inc.
Fremont, CA, US - Received
- July 5, 2016
- Decision date
- March 24, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT)GXH · Traditional | AtriCure, Inc. | 04/10/2025SE |
| 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 |
| K142866 | Myoscience iovera systemGXH · Traditional | 01/21/2015SE |
| K133453 | IoveraGXH · Traditional | 03/24/2014SE |
| K123516 | Cryo-Touch IVGXH · Traditional | 01/10/2013SE |
| K120415 | Cryo-Touch IIIGXH · Traditional | 06/22/2012SE |
| 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 iovera system cleared by the FDA?
iovera system (K161835) received a 510(k) decision of Substantially Equivalent on March 24, 2017, 262 days after the submission was received.
What is the product code of K161835?
The FDA product code is GXH – Device, Surgical, Cryogenic, a Class II (moderate risk) device regulated under 21 CFR 882.4250.