Clearance Summary
ROSEN'S STAPES NEEDLE EXPLORER received FDA 510(k) clearance under submission number K822277, sponsored by Kelleher 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 1982-08-25.
- Submission: K822277
- Applicant / Sponsor: Kelleher Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1982-08-25
Classification & Regulation
This clearance is catalogued under FDA product code KAK and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.