Clearance Summary
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES received FDA 510(k) clearance under submission number K122653, sponsored by Kimberly-Clark Corporation. 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 2013-06-26.
- Submission: K122653
- Applicant / Sponsor: Kimberly-Clark Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2013-06-26
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.