Clearance Summary
Phantom XL Insulated Dilators received FDA 510(k) clearance under submission number K231691, sponsored by TeDan Surgical Innovations, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-06-29.
- Submission: K231691
- Applicant / Sponsor: TeDan Surgical Innovations, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 2023-06-29
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.