Clearance Summary
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY received FDA 510(k) clearance under submission number K031089, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-05-08.
- Submission: K031089
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2003-05-08
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.