Clearance Summary
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U received FDA 510(k) clearance under submission number K232860, sponsored by Pentax of America, 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 2024-01-18.
- Submission: K232860
- Applicant / Sponsor: Pentax of America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4680
- Decision date: 2024-01-18
Classification & Regulation
This clearance is catalogued under FDA product code EOQ and 21 CFR 874.4680, within the Ear, Nose, Throat review panel as a Class II device.