# K960173: Infra Vision Bougie Kit, Infra Vision Esophageal Kit

- Pathway: 510(k) (Traditional)
- Applicant: Gabriel Medical, Inc.
- Decided: Jun 27, 1996 after 163 days
- Product code: FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934084 (1993). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934084: Bioenterics Endolumina Illuminating Bougie, Bioenterics Corp. (1993) Summary page 1.
- K945088: Gabriel Ureteral Illuminator System II, Gabriel Medical, Inc. (1995) Summary page 1.
- K945297: Infra Vision Imaging System, Gabriel Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K983220: Stryker Infravision Esophageal Kit (1999), 1 descendant of its own
- K130906: Endoflip Catheter (2013), 0 descendants of its own

## Indications for use
a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures; b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and c. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.

Source page: https://510kreport.com/device/K960173
Methodology: https://510kreport.com/methodology