Clearance Summary
SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET received FDA 510(k) clearance under submission number K954193, sponsored by Surgical Dynamics, 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 1995-10-23.
- Submission: K954193
- Applicant / Sponsor: Surgical Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1995-10-23
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.