Atricure Cryo Module System
510(k) K140058
Atricure Cryo Module System is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Atricure, Inc., cleared under FDA 510(k) K140058 on 24 Jan 2014, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140058 | Date24 Jan 2014 | StatusActive |
Official records
- FDA 510(k) database K140058
Recalls
-
- Ongoing Z-0927-2024
- Ongoing Z-0928-2024
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
Timeline
- Cleared FDA 510(k) K140058
- Recall initiated FDA recalls Z-0927-2024
- Recall initiated FDA recalls Z-0928-2024
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- Withdrawn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
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- MODEL C2100-SERIES OPHTHALMIC CRYOPROBE by Valleylab, Inc.
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