Clearance Summary
Neuromonitoring Kit received FDA 510(k) clearance under submission number K161893, sponsored by SI-BONE, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2016-10-18.
- Submission: K161893
- Applicant / Sponsor: SI-BONE, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2016-10-18
Classification & Regulation
This clearance is catalogued under FDA product code PDQ and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.