Clearance Summary
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX received FDA 510(k) clearance under submission number K083684, 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 2009-02-05.
- Submission: K083684
- Applicant / Sponsor: Manufacturing & Research, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2009-02-05
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.