Clearance Summary
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE received FDA 510(k) clearance under submission number K071300, 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 2007-07-20.
- Submission: K071300
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4725
- Decision date: 2007-07-20
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.