# K043605: Inscope 3-Stage Balloon Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Europa, N.V.
- Decided: Feb 4, 2005 after 36 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) Boston Scientific CRE Balloon dilatation catheter: named in the summary without a submission number

## Indications for use
The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus

Source page: https://510kreport.com/device/K043605
Methodology: https://510kreport.com/methodology