Clearance Summary
AUTO SUTURE KERRISON SPINAL RONGEUR received FDA 510(k) clearance under submission number K943116, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1994-07-27.
- Submission: K943116
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4840
- Decision date: 1994-07-27
Classification & Regulation
This clearance is catalogued under FDA product code HAE and 21 CFR 882.4840, within the Neurology review panel as a Class II device.