# K932205: Ercp Catheter, Hydrophilic Coated

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 3, 1994 after 242 days
- Product code: GBX (Catheter, Irrigation)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Oct 5, 2006 · Not classified · Z-0160-2007: Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.

Source page: https://510kreport.com/device/K932205
Methodology: https://510kreport.com/methodology