Clearance Summary
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 received FDA 510(k) clearance under submission number K062750, sponsored by Boston Scientific Corp. 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 2006-12-04.
- Submission: K062750
- Applicant / Sponsor: Boston Scientific Corp
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3610
- Decision date: 2006-12-04
Classification & Regulation
This clearance is catalogued under FDA product code MUM and 21 CFR 878.3610, within the General, Plastic Surgery review panel as a Class II device.