Clearance Summary
XPRESS BALLOON DEVICE received FDA 510(k) clearance under submission number K102003, sponsored by Entellus Medical, Inc.. 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 2010-10-22.
- Submission: K102003
- Applicant / Sponsor: Entellus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2010-10-22
Classification & Regulation
This clearance is catalogued under FDA product code LRC and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.