Clearance Summary
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY received FDA 510(k) clearance under submission number K852535, sponsored by Tri-Med Specialties, 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 1985-10-17.
- Submission: K852535
- Applicant / Sponsor: Tri-Med Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1985-10-17
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.