Clearance Summary
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM received FDA 510(k) clearance under submission number K010068, sponsored by Rusch Intl.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2001-02-08.
- Submission: K010068
- Applicant / Sponsor: Rusch Intl.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3610
- Decision date: 2001-02-08
Classification & Regulation
This clearance is catalogued under FDA product code ESW and 21 CFR 878.3610, within the General, Plastic Surgery review panel as a Class II device.