cryoICE croablation probe
510(k) K142441
cryoICE croablation probe is a Class II device made by Atricure, Inc., cleared under FDA 510(k) K142441 on 29 Oct 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142441 | Date29 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K142441
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEH
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4350
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K142441
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| cryoICE Cryoablation System CRYO3 | A000925 / CRYO3 | 00818354014549 | Length 10 cm | On the market |
Similar devices
Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).
- truFreeze System by CSA Medical
- CRYOPLAN SYSTEM by Cryomedical Sciences, Inc.
- CRYOCARE SURGICAL SYSTEM by ENDOCARE, INC.
- CRYMED CRYO-ABLATOR by Crymed Technologies, Inc.
- Freezpoint by BOVIE MEDICAL CORPORATION
- ERBECRYO 2 Cryosurgical Unit and Accessories by Erbe Elektromedizin GmbH
- IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) by Boston Scientific
- MIC-100 WITH CRYOPROBES by Frigitronics of Connecticut, Inc.
- KRYMED LIQUID NITROGEN CRYOJET by Cryomedics, Inc.
- POLAR WAND by Chek-Med Systems