Clearance Summary
IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT received FDA 510(k) clearance under submission number K092049, sponsored by Sainath Intellectual Properties, LLC. 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 2009-10-09.
- Submission: K092049
- Applicant / Sponsor: Sainath Intellectual Properties, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2009-10-09
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.