Clearance Summary
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs received FDA 510(k) clearance under submission number K150468, sponsored by K2 Medical GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-02-29.
- Submission: K150468
- Applicant / Sponsor: K2 Medical GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 2016-02-29
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.