# K061937: Cook Endoscopy Esophageal Dilation Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Cook Endoscopy
- Decided: Dec 1, 2006 after 144 days
- Product code: KNQ (Dilator, Esophageal)
- 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 K935094 (1995). 2 ancestors in all.
1 later device descends 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)
- K935094: Balloon Dilation Catheter, Wilson-Cook Medical, Inc. (1995) Summary page 1.
- K001338: Microvasive Rapid Exchange Biliary Balloon Dilatation Catheter, Boston Scientific Corp (2000)

## Most influential descendants
- K080158: LB Medical Inflatable Tissue Elevator/Expander System (2008), 0 descendants of its own

## Indications for use
The Esophageal Balloon Dilator is used to endoscopically dilate strictures of the esophagus.

Source page: https://510kreport.com/device/K061937
Methodology: https://510kreport.com/methodology