Clearance Summary
TRIGEMINAL SCISSORS received FDA 510(k) clearance under submission number K890261, sponsored by Kinetic Medical 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 1989-01-27.
- Submission: K890261
- Applicant / Sponsor: Kinetic Medical Products
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1989-01-27
Classification & Regulation
This clearance is catalogued under FDA product code HRR and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.