ClariFix Device
510(k) K160669
ClariFix Device is a medical device (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by Arrinex, Inc., cleared under FDA 510(k) K160669 on 24 Jun 2016, 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 | NumberK160669 | Date24 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K160669
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- Withdrawn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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