Clearance Summary
RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 received FDA 510(k) clearance under submission number K984521, 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 1999-03-17.
- Submission: K984521
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4750
- Decision date: 1999-03-17
Classification & Regulation
This clearance is catalogued under FDA product code EQL and 21 CFR 874.4750, within the Ear, Nose, Throat review panel as a Class I device.