Clearance Summary
SURGICAL IRRIGATION DEVICE (SID)/ARTHROSCOPIC SURG received FDA 510(k) clearance under submission number K854737, sponsored by Orthopaedic Devices , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1986-05-19.
- Submission: K854737
- Applicant / Sponsor: Orthopaedic Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5475
- Decision date: 1986-05-19
Classification & Regulation
This clearance is catalogued under FDA product code FQH and 21 CFR 880.5475, within the General Hospital review panel as a Class II device.