Clearance Summary
MICRO-AIRE STAPES DRILL SYSTEM received FDA 510(k) clearance under submission number K854332, sponsored by Micro-Aire Surgical Instruments, 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 1986-01-21.
- Submission: K854332
- Applicant / Sponsor: Micro-Aire Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 1986-01-21
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.