Clearance Summary
DISPOSABLE ARACHNOID KNIFE received FDA 510(k) clearance under submission number K882422, sponsored by Microbio-Medics, 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 1988-09-06.
- Submission: K882422
- Applicant / Sponsor: Microbio-Medics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4535
- Decision date: 1988-09-06
Classification & Regulation
This clearance is catalogued under FDA product code HAO and 21 CFR 882.4535, within the Neurology review panel as a Class I device.