Clearance Summary
MCINTYRE MICROSCOPE STAND received FDA 510(k) clearance under submission number K822426, sponsored by Surgi-Quip Inc.U. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1982-09-02.
- Submission: K822426
- Applicant / Sponsor: Surgi-Quip Inc.U
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4125
- Decision date: 1982-09-02
Classification & Regulation
This clearance is catalogued under FDA product code HBN and 21 CFR 882.4125, within the Neurology review panel as a Class I device.