# K934084: Bioenterics Endolumina Illuminating Bougie

- Pathway: 510(k) (Traditional)
- Applicant: Bioenterics Corp.
- Decided: Dec 16, 1993 after 118 days
- Product code: HMJ (Screen, Tangent, Projection, Battery-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K960173: Infra Vision Bougie Kit, Infra Vision Esophageal Kit (1996), 2 descendants of its own
- K983220: Stryker Infravision Esophageal Kit (1999), 1 descendant of its own
- K130906: Endoflip Catheter (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K934084
Methodology: https://510kreport.com/methodology