Clearance Summary
GRIESHABER THREE FUNCTION MANIPULATOR received FDA 510(k) clearance under submission number K914586, sponsored by Grieshaber & Co.. 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 1992-01-03.
- Submission: K914586
- Applicant / Sponsor: Grieshaber & Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4350
- Decision date: 1992-01-03
Classification & Regulation
This clearance is catalogued under FDA product code EQH and 21 CFR 874.4350, within the Ear, Nose, Throat review panel as a Class I device.