Clearance Summary
MIC-KEY GLOW PROFILE GASTROSTOMY REPLACEMENT KIT received FDA 510(k) clearance under submission number K982894, sponsored by Ballard Medical Products. 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 1998-09-11.
- Submission: K982894
- Applicant / Sponsor: Ballard Medical Products
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1998-09-11
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.