Clearance Summary
Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS received FDA 510(k) clearance under submission number K143159, sponsored by Spineguard S.A.. 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 2015-01-23.
- Submission: K143159
- Applicant / Sponsor: Spineguard S.A.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2015-01-23
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.