# K993063: Rusch Brillant Silicone Foley

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Dec 9, 1999 after 87 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.
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) Willy Risch AG.: named in the summary without a submission number
- (no number) Sherwood Medical: named in the summary without a submission number
- (no number) Kendall: named in the summary without a submission number
- (no number) Baxter: named in the summary without a submission number
- (no number) Bard: named in the summary without a submission number

## Indications for use
The Rusch Brillant Two Way Silicone Foley is used to drain fluids to and from the urinary tract. The Risch Brillant Three Way Silicone Foley is used to drain fluids to and from the urinary tract, and to flush and irrigate the urinary tract.

Source page: https://510kreport.com/device/K993063
Methodology: https://510kreport.com/methodology