Clearance Summary
PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT received FDA 510(k) clearance under submission number K040415, sponsored by Synovis Surgical Innovations. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-04-14.
- Submission: K040415
- Applicant / Sponsor: Synovis Surgical Innovations
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3470
- Decision date: 2004-04-14
Classification & Regulation
This clearance is catalogued under FDA product code DXZ and 21 CFR 870.3470, within the Cardiovascular review panel as a Class II device.