Clearance Summary
RENTON SUCTION DEVICE U.S. PATENT*4,767,404 received FDA 510(k) clearance under submission number K962920, sponsored by R&S Surgical, LLC. 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 1996-10-21.
- Submission: K962920
- Applicant / Sponsor: R&S Surgical, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1996-10-21
Classification & Regulation
This clearance is catalogued under FDA product code GCX and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.