# K013172: Porges Silicone Prostatectomy Catheter, Straight Cylindrical Tip, Delinotte Tip, Dufour Tip, Over the Guide Tip, Model

- Pathway: 510(k) (Abbreviated)
- Applicant: Porges S.A.
- Decided: Dec 20, 2001 after 87 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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. 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) Bardex® All-silicone 3-way Foley catheter from BARD: named in the summary without a submission number

## Recalls of this device
- Dec 2, 2024 · Class II · Z-0845-2025: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

## Indications for use
The PORGES™ Silicone prostatectomy catheter is used for : - short term drainage of the vesical urines, - irrigation/injection and drainage following surgery, - after prostate surgery : hemostasis of the prostate area.

Source page: https://510kreport.com/device/K013172
Methodology: https://510kreport.com/methodology