Clearance Summary
OTOVIEW ENDOSCOPY SYSTEM received FDA 510(k) clearance under submission number K934432, sponsored by Smith & Nephew Richards, 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 1994-04-25.
- Submission: K934432
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.1080
- Decision date: 1994-04-25
Classification & Regulation
This clearance is catalogued under FDA product code EWA and 21 CFR 874.1080, within the Ear, Nose, Throat review panel as a Class I device.