Clearance Summary
LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE received FDA 510(k) clearance under submission number K853708, sponsored by Downs Surgical , Ltd.. 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 1986-02-14.
- Submission: K853708
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1986-02-14
Classification & Regulation
This clearance is catalogued under FDA product code KAE and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.