Clearance Summary
FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT received FDA 510(k) clearance under submission number K885339, sponsored by Superior Healthcare Group, 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 1989-03-01.
- Submission: K885339
- Applicant / Sponsor: Superior Healthcare Group, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1989-03-01
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.