Clearance Summary
PERCUTANEOUS GASTROSTOMY TUBE received FDA 510(k) clearance under submission number K842174, sponsored by Mount Carmel Mercy Hospital. 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 1984-12-07.
- Submission: K842174
- Applicant / Sponsor: Mount Carmel Mercy Hospital
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1984-12-07
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.