Clearance Summary
FAS ENDOLUMINAL BRUSH received FDA 510(k) clearance under submission number K012641, sponsored by Fas Medical , 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 2001-10-15.
- Submission: K012641
- Applicant / Sponsor: Fas Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2001-10-15
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.