Clearance Summary
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT received FDA 510(k) clearance under submission number K960173, sponsored by Gabriel Medical, 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 1996-06-27.
- Submission: K960173
- Applicant / Sponsor: Gabriel Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5365
- Decision date: 1996-06-27
Classification & Regulation
This clearance is catalogued under FDA product code FAT and 21 CFR 876.5365, within the Gastroenterology, Urology review panel as a Class II device.