Clearance Summary
TRI-MED INFLATABLE ESOPHAGEAL DILATOR received FDA 510(k) clearance under submission number K932015, 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 1994-02-03.
- Submission: K932015
- Applicant / Sponsor: Tri-Med Specialties, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 1994-02-03
Classification & Regulation
This clearance is catalogued under FDA product code KNQ and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.