Clearance Summary
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP received FDA 510(k) clearance under submission number K100548, sponsored by Covidien Lp, Formerly Registered AS Tyco Healthcar. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2010-04-26.
- Submission: K100548
- Applicant / Sponsor: Covidien Lp, Formerly Registered AS Tyco Healthcar
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-04-26
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.