Clearance Summary
ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444 received FDA 510(k) clearance under submission number K901735, sponsored by Micro-Aire Surgical Instruments, 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 1990-06-20.
- Submission: K901735
- Applicant / Sponsor: Micro-Aire Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1990-06-20
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.