Clearance Summary
CO2 LASER BRONCHOSCOPE SYSTEM received FDA 510(k) clearance under submission number K861583, sponsored by Richard Wolf Medical 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 1986-05-21.
- Submission: K861583
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4500
- Decision date: 1986-05-21
Classification & Regulation
This clearance is catalogued under FDA product code LLO and 21 CFR 874.4500, within the Ear, Nose, Throat review panel as a Class II device.