Clearance Summary
SMITH & NEPHEW RF CANNULATE received FDA 510(k) clearance under submission number K090955, sponsored by Smith & Nephew, 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 2009-07-16.
- Submission: K090955
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2009-07-16
Classification & Regulation
This clearance is catalogued under FDA product code GXI and 21 CFR 882.4725, within the Neurology review panel as a Class II device.