Clearance Summary
ARTHROSCOPE received FDA 510(k) clearance under submission number K971083, sponsored by Electro-Biology, 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 1997-06-23.
- Submission: K971083
- Applicant / Sponsor: Electro-Biology, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1997-06-23
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.