Clearance Summary
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, received FDA 510(k) clearance under submission number K103128, sponsored by Cadwell Lab, 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 2011-02-23.
- Submission: K103128
- Applicant / Sponsor: Cadwell Lab, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2011-02-23
Classification & Regulation
This clearance is catalogued under FDA product code ETN and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.