cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
FDA 510(k) clearance K233170 · decided 2023-10-26
Clearance details
- K-number
- K233170
- Device name
- cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)
- Applicant
- AtriCure, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-27
- Decision date
- 2023-10-26
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GXH
- Device class
- 2
- Regulation number
- 882.4250
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mason, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| cryoICE cryoXT cryoablation probe (cryoXT) (K250371) | AtriCure, Inc. | 2025-04-10 |
| iovera° System (K243677) | Pacira Biosciences, Inc. | 2024-12-26 |
| AtriCure cryoICE BOX (ACM) (K243157) | AtriCure, Inc. | 2024-10-29 |
| iovera System (K220656) | Pacira Biosciences, Inc. | 2022-05-20 |
| Iovera System (K211334) | Pacira Pharmaceuticals, Inc. | 2021-09-10 |
| AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K200697) | AtriCure, Inc. | 2020-12-23 |
| AtriCure cryoICE cryoSPHERE cryoablation probe (K182565) | AtriCure, Inc. | 2018-11-09 |
| iovera system (K173763) | Myoscience, Inc. | 2018-02-28 |
| AtriCure cryoICE cryo-ablation probe (CRYO2) (K180138) | AtriCure, Inc. | 2018-02-15 |
| iovera system (K161835) | Myoscience, Inc. | 2017-03-24 |
| Myoscience iovera system (K142866) | Myoscience, Inc. | 2015-01-21 |
| Atricure Cryo Module System; cryoICE cryoablation probe (K142203) | AtriCure, Inc. | 2014-11-25 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EPi-Sense ST Coagulation System (P200002/S013) | AtriCure, Inc. | 2025-11-14 |
| EPi-Sense Guided Coagulation System (P200002/S012) | AtriCure, Inc. | 2025-10-07 |
| Synergy Ablation System (P100046/S019) | AtriCure, Inc. | 2025-06-17 |
| EPi-Sense Guided Coagulation System (P200002/S011) | AtriCure, Inc. | 2025-06-17 |
| EPi-Sense and EPi-Sense ST Guided Coagulation System (P200002/S010) | AtriCure, Inc. | 2025-03-03 |
| Cannula with Guide (P200002/S009) | AtriCure, Inc. | 2024-08-28 |
| Synergy Ablation System (P100046/S018) | AtriCure, Inc. | 2024-03-15 |
| EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S008) | AtriCure, Inc. | 2023-12-11 |