Clearance Summary
ARTHROSCOPY PUMP, MODEL A107 received FDA 510(k) clearance under submission number K030402, sponsored by W.O.M. World of Medicine AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-04-17.
- Submission: K030402
- Applicant / Sponsor: W.O.M. World of Medicine AG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 2003-04-17
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.