Clearance Summary
Smith+Nephew Arthroscopes received FDA 510(k) clearance under submission number K201349, sponsored by Smith & Nephew. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-07-20.
- Submission: K201349
- Applicant / Sponsor: Smith & Nephew
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2020-07-20
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.