510(k) K142866
- Device
- Myoscience Iovera System
- Applicant
- Myoscience, Inc
- 510(k) number
- K142866
- Product code
- GXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-21
- Date received
- 2014-10-01
- Regulation
- 882.4250
- Classification name
- Device, Surgical, Cryogenic
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tracey Henry
- Address
- 1600 Seaport Blvd., N. Lobby, Suite 450 Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3009746061
- 3013944123
- 1424263
- 3020706315
- 3011706110
- 1643059
- 1450662
- 1316297
- 1526711
- 2011171
Source Documents#
Other 510(k) Records For Product Code GXH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | 2025-04-10 |
| K243677 | iovera° System | Pacira Biosciences, Inc. | 2024-12-26 |
| K243157 | AtriCure cryoICE BOX (ACM) | AtriCure, Inc. | 2024-10-29 |
| K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L) | AtriCure, Inc. | 2023-10-26 |
| K220656 | iovera System | Pacira Biosciences, Inc. | 2022-05-20 |
| K211334 | Iovera System | Pacira Pharmaceuticals, Inc. | 2021-09-10 |
| K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) | AtriCure, Inc. | 2020-12-23 |
| K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018-11-09 |
| K173763 | iovera system | Myoscience, Inc. | 2018-02-28 |
| K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018-02-15 |
| K161835 | iovera system | Myoscience, Inc. | 2017-03-24 |
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014-11-25 |
| K133453 | IOVERA | Myoscience, Inc. | 2014-03-24 |
| K123516 | CRYO-TOUCH IV | Myoscience, Inc. | 2013-01-10 |
| K120415 | CRYO-TOUCH III | Myoscience, Inc. | 2012-06-22 |
Legacy Summary#
summary
FDA Review#
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