Clearance Summary
MITEK SUTURE RETROGRADER received FDA 510(k) clearance under submission number K970360, sponsored by Mitek Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-03-10.
- Submission: K970360
- Applicant / Sponsor: Mitek Products
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1997-03-10
Classification & Regulation
This clearance is catalogued under FDA product code HWQ and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.