Clearance Summary
CRANIOTOME BLADE OR NEURO BLADE received FDA 510(k) clearance under submission number K881418, sponsored by Nuell Air Equipment & Hospital Supplies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-05-31.
- Submission: K881418
- Applicant / Sponsor: Nuell Air Equipment & Hospital Supplies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 1988-05-31
Classification & Regulation
This clearance is catalogued under FDA product code HBE and 21 CFR 882.4310, within the Neurology review panel as a Class II device.