# K974419: Rusch Simplastic Councill Tip Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rusch, Inc.
- Decided: Jan 27, 1998 after 64 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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) Porges Graham® Catheter: named in the summary without a submission number

## Most influential descendants
- K042110: Beamcath (2005), 3 descendants of its own
- K131655: Lighthouse (TM) Urinary Catheter (2013), 1 descendant of its own
- K140099: Lighthouse Urinary Catheter (2014), 0 descendants of its own
- K082919: UC-Care Positioning System (2008), 0 descendants of its own

## Indications for use
The Device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra

Source page: https://510kreport.com/device/K974419
Methodology: https://510kreport.com/methodology