Clearance Summary
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 received FDA 510(k) clearance under submission number K060323, sponsored by Boston Scientific Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2006-05-12.
- Submission: K060323
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3610
- Decision date: 2006-05-12
Classification & Regulation
This clearance is catalogued under FDA product code MQR and 21 CFR 878.3610, within the General, Plastic Surgery review panel as a Class II device.