Clearance Summary
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE received FDA 510(k) clearance under submission number K990863, sponsored by Ross Product Div. Abbott Laboratories. 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 1999-04-06.
- Submission: K990863
- Applicant / Sponsor: Ross Product Div. Abbott Laboratories
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1999-04-06
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.