# K060302: Inscope Precision Balloon Dilator - Wire Guided

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Europa, N.V.
- Decided: Apr 11, 2006 after 64 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) InScope Precision Balloon Dilator - Fixed Wire: named in the summary without a submission number
- (no number) Boston Scientific's CRE Wireguided Balloon Dilator: 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 alimentary tract (i.e. esophagus, pylorus and colon).

Source page: https://510kreport.com/device/K060302
Methodology: https://510kreport.com/methodology