Clearance Summary
ENTREE CANNULA received FDA 510(k) clearance under submission number K911813, sponsored by Core Dynamics, Inc.. 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 1991-07-19.
- Submission: K911813
- Applicant / Sponsor: Core Dynamics, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5090
- Decision date: 1991-07-19
Classification & Regulation
This clearance is catalogued under FDA product code FBM and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class I device.