Clearance Summary
SX-One MicroKnife received FDA 510(k) clearance under submission number K192873, sponsored by Sonex Health, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-12-20.
- Submission: K192873
- Applicant / Sponsor: Sonex Health, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2019-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LXH and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.