Clearance Summary
EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS received FDA 510(k) clearance under submission number K900680, sponsored by Effner, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-03-29.
- Submission: K900680
- Applicant / Sponsor: Effner, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1990-03-29
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.