ClariFix
510(k) K190356
ClariFix is a Class II device made by Arrinex, Inc., cleared under FDA 510(k) K190356 on 26 Feb 2019, 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 | NumberK190356 | Date26 Feb 2019 | StatusActive |
Official records
- FDA 510(k) database K190356
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- Withdrawn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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