Clearance Summary
SILS PORT received FDA 510(k) clearance under submission number K103253, sponsored by Coviden (Formerly Registered AS US Surgical, A Div. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2011-02-24.
- Submission: K103253
- Applicant / Sponsor: Coviden (Formerly Registered AS US Surgical, A Div
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2011-02-24
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.