Clearance Summary
SMITH & NEPHEW CDS SYSTEM received FDA 510(k) clearance under submission number K081491, sponsored by Smith & Nephew, 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 2008-06-19.
- Submission: K081491
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2008-06-19
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.