Clearance Summary
AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT received FDA 510(k) clearance under submission number K893707, sponsored by United States Surgical, A Division of Tyco Healthc. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-06-15.
- Submission: K893707
- Applicant / Sponsor: United States Surgical, A Division of Tyco Healthc
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1390
- Decision date: 1989-06-15
Classification & Regulation
This clearance is catalogued under FDA product code DRC and 21 CFR 870.1390, within the Cardiovascular review panel as a Class II device.