Clearance Summary
Universal Mesh - Sterile received FDA 510(k) clearance under submission number K182425, sponsored by Stryker Leibinger GmbH & Co KG. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-11-06.
- Submission: K182425
- Applicant / Sponsor: Stryker Leibinger GmbH & Co KG
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5320
- Decision date: 2018-11-06
Classification & Regulation
This clearance is catalogued under FDA product code GWO and 21 CFR 882.5320, within the Neurology review panel as a Class II device.