Clearance Summary
DRILL MODULES MODELS 2116/2117 received FDA 510(k) clearance under submission number K914346, sponsored by Micro Surgical Instruments Corp.. 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 1991-11-27.
- Submission: K914346
- Applicant / Sponsor: Micro Surgical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 1991-11-27
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.