Crymed Cryo-Ablator
510(k) K040809
Crymed Cryo-Ablator is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Crymed Technologies, Inc., cleared under FDA 510(k) K040809 on 21 May 2004, 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 | NumberK040809 | Date21 May 2004 | StatusActive |
Official records
- FDA 510(k) database K040809
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- Withdrawn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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- Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System by C2 THERAPEUTICS, INC.