Clearance Summary
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 received FDA 510(k) clearance under submission number K211490, sponsored by Stryker Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-06-09.
- Submission: K211490
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 2021-06-09
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.