Clearance Summary
LOCKING WIRE GUIDE STYLET received FDA 510(k) clearance under submission number K890820, sponsored by Medical Engineering and Development Institute. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-03-22.
- Submission: K890820
- Applicant / Sponsor: Medical Engineering and Development Institute
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1989-03-22
Classification & Regulation
This clearance is catalogued under FDA product code GAD and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.