Clearance Summary
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT received FDA 510(k) clearance under submission number K963246, sponsored by Medtronic Xomed. 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 1996-09-23.
- Submission: K963246
- Applicant / Sponsor: Medtronic Xomed
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 1996-09-23
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.