Clearance Summary
KLS Martin Neuro Rongeurs received FDA 510(k) clearance under submission number K210741, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-06-03.
- Submission: K210741
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 2022-06-03
Classification & Regulation
This clearance is catalogued under FDA product code HAE and 21 CFR 882.4840, within the Neurology review panel as a Class II device.