Clearance Summary
ENTHERMO IRRIGATION UNIT received FDA 510(k) clearance under submission number K863615, sponsored by Jedmed Instrument 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 1986-12-16.
- Submission: K863615
- Applicant / Sponsor: Jedmed Instrument Co.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.1800
- Decision date: 1986-12-16
Classification & Regulation
This clearance is catalogued under FDA product code ETP and 21 CFR 874.1800, within the Ear, Nose, Throat review panel as a Class I device.