Clearance Summary
PENTAX Medical EPK-3000 Video Imaging System received FDA 510(k) clearance under submission number K182846, sponsored by Pentax of America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2019-01-09.
- Submission: K182846
- Applicant / Sponsor: Pentax of America, Inc.
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 2019-01-09
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.