# K892855: Urethral Balloon Dilation Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Nov 17, 1989 after 213 days
- Product code: KOE (Dilator, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5520
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 4, 2019 · Class II · Z-0970-2020: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Source page: https://510kreport.com/device/K892855
Methodology: https://510kreport.com/methodology