Clearance Summary
DYONICS DISPOSABLE ARTHROSCOPIC SURGERY BLADES MODIFICATION received FDA 510(k) clearance under submission number K934299, sponsored by Smith & Nephew Dyonics, 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 1994-02-14.
- Submission: K934299
- Applicant / Sponsor: Smith & Nephew Dyonics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1994-02-14
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.