# K182895: Wilson-Cook Achalasia Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 25, 2019 after 102 days
- Product code: PID (Esophageal Dilator Balloon With Or Without Electrode Sensors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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 K050232 (2005). 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)
- K050232: Rigiflex Single-Use Achalasia Balloon Dilator, Boston Scientific Corp (2005) Summary page 4.

## Indications for use
The device is used to dilate the lower esophageal sphincter in patients with Achalasia. This device is indicated for adult use only.

Source page: https://510kreport.com/device/K182895
Methodology: https://510kreport.com/methodology