Clearance Summary
MRI'S ALL SILICONE GASTROSTOMY TUBE received FDA 510(k) clearance under submission number K951489, sponsored by Manufacturing & Research, 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 1995-06-07.
- Submission: K951489
- Applicant / Sponsor: Manufacturing & Research, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1995-06-07
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.