# K990935: Jackson Esophageal Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Pilling Weck Surgical
- Decided: May 17, 1999 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Jackson Esophageal Dilator made with Cyanoacrylate: named in the summary without a submission number

## Indications for use
To be used for exploration and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.

Source page: https://510kreport.com/device/K990935
Methodology: https://510kreport.com/methodology