# K964575: Sympacath Hydrogel Coated Foley

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Feb 4, 1997 after 82 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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) Bard Biocath: named in the summary without a submission number
- (no number) Lubricath: named in the summary without a submission number
- (no number) Curity Kendall Ultramer coated catheters: named in the summary without a submission number

## Most influential descendants
- K033023: Intermittent Urethral Catheters (2003), 9 descendants of its own
- K072539: Cure Catheter (2007), 5 descendants of its own
- K110653: Cure Catheter (2011), 4 descendants of its own
- K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated (2013), 3 descendants of its own
- K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter, (2012), 2 descendants of its own

## Indications for use
This device is a urological catheter, which is a tubular device that is inserted through the urethra and is used to pass fluids to or from the urinary tract.

Source page: https://510kreport.com/device/K964575
Methodology: https://510kreport.com/methodology