Clearance Summary
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing received FDA 510(k) clearance under submission number K151932, sponsored by Stryker Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-03-31.
- Submission: K151932
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2016-03-31
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.