Clearance Summary
PHANTOM XL INSULATED DILATORS received FDA 510(k) clearance under submission number K140088, sponsored by Tedan Surgical Innovations, LLC. 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 2014-09-25.
- Submission: K140088
- Applicant / Sponsor: Tedan Surgical Innovations, LLC
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2014-09-25
Classification & Regulation
This clearance is catalogued under FDA product code PDQ and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.