Clearance Summary
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR received FDA 510(k) clearance under submission number K894653, sponsored by Superior Biosystems, 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 1989-12-21.
- Submission: K894653
- Applicant / Sponsor: Superior Biosystems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1989-12-21
Classification & Regulation
This clearance is catalogued under FDA product code KGC and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.