About This 510(k) Submission
K960173 is an FDA 510(k) clearance for the INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT, a Bougie, Esophageal, And Gastrointestinal, Gastro-urology (Class II — Special Controls, product code FAT), submitted by Gabriel Medical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 27, 1996, 163 days after receiving the submission on January 16, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.