Clearance Summary
ARTHOSCOPY PUMP A115 received FDA 510(k) clearance under submission number K033927, sponsored by W.O.M. World of Medicine AG. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-01-15.
- Submission: K033927
- Applicant / Sponsor: W.O.M. World of Medicine AG
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2004-01-15
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.