# K090183: Hercules 3 Stage Wire Guided Dilation Balloon

- Pathway: 510(k) (Special)
- Applicant: Cook Endoscopy
- Decided: Sep 25, 2009 after 242 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). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
Used to dilate strictures of the gastrointestinal tract, including strictures of the esophagus, pylorus, duodenum and colon.

Source page: https://510kreport.com/device/K090183
Methodology: https://510kreport.com/methodology