Clearance Summary
XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL received FDA 510(k) clearance under submission number K912753, sponsored by Xomed-Treace, Inc.. 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 1991-09-23.
- Submission: K912753
- Applicant / Sponsor: Xomed-Treace, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1991-09-23
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.