iovera System
FDA 510(k) K220656 · Pacira Biosciences, Inc.
510(k) numberK220656
Submission
- Device name
- iovera System
- Applicant
- Pacira Biosciences, Inc.
San Diego, CA, US - Received
- March 7, 2022
- Decision date
- May 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
| K161835 | iovera systemGXH · Traditional | Myoscience, Inc. | 03/24/2017SE |
More from Myoscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243677 | iovera° SystemGXH · Special | 12/26/2024SE |
Questions and answers
When was iovera System cleared by the FDA?
iovera System (K220656) received a 510(k) decision of Substantially Equivalent on May 20, 2022, 74 days after the submission was received.
What is the product code of K220656?
The FDA product code is GXH – Device, Surgical, Cryogenic, a Class II (moderate risk) device regulated under 21 CFR 882.4250.