Clearance Summary
NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe received FDA 510(k) clearance under submission number K180542, sponsored by Boston Endo Surgical Tech,. 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 2018-08-22.
- Submission: K180542
- Applicant / Sponsor: Boston Endo Surgical Tech,
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2018-08-22
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.