# K983220: Stryker Infravision Esophageal Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Jun 4, 1999 after 263 days
- Product code: FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5365
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934084 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960173: Infra Vision Bougie Kit, Infra Vision Esophageal Kit, Gabriel Medical, Inc. (1996) Summary page 1.
- K863437: Bard Balloon Dilatation System, C.R. Bard, Inc. (1986) Summary page 1.
- K810156: Argyle Salem Sump Tube, Sherwood Medical Co. (1981) Summary page 1.
- K934084: Bioenterics Endolumina Illuminating Bougie, Bioenterics Corp. (1993). Our OCR of the scanned summary read K934048, FDA’s number for GH Gloves (Powder Free) (Grafik Hersteller Sdn Bhd). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “BioEnterics EndoLumina Illuminated Bougie”.

## Most influential descendants
- K130906: Endoflip Catheter (2013), 0 descendants of its own

## Recalls of this device
- May 11, 2010 · Not classified · Z-1002-2011: The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
- Aug 20, 2009 · Not classified · Z-0830-2011: The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.

## Indications for use
The Stryker InfraVision™ Esophageal Kit is an esophageal transillumination dilation device with a reusable illumination source, and a combined single use disposable fiberoptic light guide, nasogastric tube and balloon dilation system. The Stryker InfraVision™ Esophageal Kit is intended w0 wansilluminate and dilate the esaphagus during, the fundoplication procedure as well as other thoracoscopic, laparoscopic, or open surgical procedures. Transillumination is intended to help the surgeon identify organs and placement of medical devices within body tissue.

Source page: https://510kreport.com/device/K983220
Methodology: https://510kreport.com/methodology