Clearance Summary
Smith & Nephew 25 Fluid Management System received FDA 510(k) clearance under submission number K171794, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-06-27.
- Submission: K171794
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2017-06-27
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.