Clearance Summary
Flow-Nail received FDA 510(k) clearance under submission number K234075, sponsored by Flow-Fx, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-02-05.
- Submission: K234075
- Applicant / Sponsor: Flow-Fx, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 2024-02-05
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.