# K945297: Infra Vision Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Gabriel Medical, Inc.
- Decided: Dec 20, 1994 after 50 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- 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; 1 cites 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 has not posted a summary or statement for it, 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

## Recalls of this device
- Sep 29, 2010 · Not classified · Z-0906-2011: Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.

Source page: https://510kreport.com/device/K945297
Methodology: https://510kreport.com/methodology