Clearance Summary
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE received FDA 510(k) clearance under submission number K043114, sponsored by Kimberly-Clark Corp.. 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 2004-12-10.
- Submission: K043114
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2004-12-10
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.