GXH
- Product code
- GXH
- Device name
- Device, Surgical, Cryogenic
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4250
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 23
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250371 | 2025-04-10 | AtriCure, Inc. | cryoICE cryoXT cryoablation probe (cryoXT) | |
| K243677 | 2024-12-26 | Pacira Biosciences, Inc. | iovera° System | |
| K243157 | 2024-10-29 | AtriCure, Inc. | AtriCure cryoICE BOX (ACM) | |
| K233170 | 2023-10-26 | AtriCure, Inc. | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cry |
Official FDA classification page: GXH
Classification and pathway per current FDA publications. Data from openFDA (CC0).