Clearance Summary
SURGICAL DYNAMICS MENISCAL STAPLE received FDA 510(k) clearance under submission number K013890, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-12-11.
- Submission: K013890
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2001-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HWC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.