Clearance Summary
PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor received FDA 510(k) clearance under submission number K181292, sponsored by Cogentix Medical, 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 2018-11-15.
- Submission: K181292
- Applicant / Sponsor: Cogentix Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4710
- Decision date: 2018-11-15
Classification & Regulation
This clearance is catalogued under FDA product code EOX and 21 CFR 874.4710, within the Ear, Nose, Throat review panel as a Class II device.