Clearance Summary
SHAH SELF-CLEARING MASTOID SUCTION TUBE received FDA 510(k) clearance under submission number K853589, 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 1985-12-23.
- Submission: K853589
- 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: 1985-12-23
Classification & Regulation
This clearance is catalogued under FDA product code JZF and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.