truFreeze System
by CSA Medical, Inc. 9 variants
510(k) K172041
truFreeze System is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by CSA Medical, Inc., cleared under FDA 510(k) K172041 on 27 Jul 2017, 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 | NumberK172041 | Date27 Jul 2017 | StatusActive |
Official records
- FDA 510(k) database K172041
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- Withdrawn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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- Verruca-Freeze® H by Cryosurgery, Inc.
- CRYOLYZER ALPHA (CRYOSURG.EQUIP.) by Cryo-Labs, Inc.
- CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU. by Stiefel Research Institute, Inc.
- Verruca-Freeze H Plus by Cryosurgery, Inc.