Clearance Summary
SINUSCOPE AND ACCESSORIES received FDA 510(k) clearance under submission number K981751, sponsored by Henke Sass Wolf 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 1998-08-13.
- Submission: K981751
- Applicant / Sponsor: Henke Sass Wolf of America, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4760
- Decision date: 1998-08-13
Classification & Regulation
This clearance is catalogued under FDA product code EOB and 21 CFR 874.4760, within the Ear, Nose, Throat review panel as a Class II device.