Clearance Summary
FIXATION STYLETS, MODELS 335-287 AND 335-288 received FDA 510(k) clearance under submission number K000366, sponsored by Accufix Research Institute. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2000-04-14.
- Submission: K000366
- Applicant / Sponsor: Accufix Research Institute
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1380
- Decision date: 2000-04-14
Classification & Regulation
This clearance is catalogued under FDA product code DRB and 21 CFR 870.1380, within the Cardiovascular review panel as a Class II device.