Clearance Summary
HERCULON SOFT TISSUE REATTACHMENT SYSTEM received FDA 510(k) clearance under submission number K040594, 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 2004-03-31.
- Submission: K040594
- 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: 2004-03-31
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.