Clearance Summary
CORGRIP NG/NI Tube Retention System received FDA 510(k) clearance under submission number K162110, sponsored by Corpak Medsystems, Inc. A Division of Haylard Health. 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 2016-09-15.
- Submission: K162110
- Applicant / Sponsor: Corpak Medsystems, Inc. A Division of Haylard Health
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2016-09-15
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.