Clearance Summary
PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System received FDA 510(k) clearance under submission number K213235, 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 2022-12-21.
- Submission: K213235
- 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: 2022-12-21
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.