Clearance Summary
GORE INTRODUCER SHEATH received FDA 510(k) clearance under submission number K013282, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2001-12-14.
- Submission: K013282
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5520
- Decision date: 2001-12-14
Classification & Regulation
This clearance is catalogued under FDA product code DBY and 21 CFR 866.5520, within the Immunology review panel as a Class I device.