# K013174: Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley Catheter, Straight Cylindrical,

- Pathway: 510(k) (Abbreviated)
- Applicant: Porges S.A.
- Decided: Jan 4, 2002 after 102 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) modified paediatric silicone Foley catheter from PORGES: named in the summary without a submission number
- (no number) silicone Foley catheters from ROCHESTER, Inc.: named in the summary without a submission number
- (no number) Bardex® All-silicone 3-way Foley catheter from BARD: named in the summary without a submission number
- (no number) Oligon® Foley Catheter from IMPLEMED: named in the summary without a submission number

## Most influential descendants
- K233411: Folysil Silicone Catheter (2024), 0 descendants of its own

## Indications for use
The 2-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation for short term drainage of vesical urines. Only straight 2-way PORGES™ FOLYSIL™ silicone Foley catheter with a maximum 15 mil balloon volume may be used in a supra-pubic way (except the grooved catheters). The 3-way PORGES™ FOLYSIL™ silicone Foley catheter is used for urethral urinary catheterisation to allow short term drainage of the vesical urines, irrigation/injection following surgery.

Source page: https://510kreport.com/device/K013174
Methodology: https://510kreport.com/methodology