Clearance Summary
PRECLUDE SYNBLOC MEMBRANE received FDA 510(k) clearance under submission number K961802, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1996-07-31.
- Submission: K961802
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5900
- Decision date: 1996-07-31
Classification & Regulation
This clearance is catalogued under FDA product code GXO and 21 CFR 882.5900, within the Neurology review panel as a Class II device.