# K233411: Folysil Silicone Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Apr 15, 2024 after 192 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
Longest line of descent: 1 generation back to K900031 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013174: Proges Folysil Silicone Foley Catheter, Straight Cylindrical Tip, Silicone Female Foley Catheter, Straight Cylindrical,, Porges S.A. (2002) Summary page 5.
- K900031: Modified Pediatric Silicone Foley Catheters, Porges Corp. (1990) Summary page 5.

## Recalls of this device
- Dec 2, 2024 · Class II · Z-0844-2025: A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

## Indications for use
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for: - Bladder drainage by urethral catheterization, - Bladder drainage by suprapubic catheterization for catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL). - Bladder instillation of physiological saline solution.

Source page: https://510kreport.com/device/K233411
Methodology: https://510kreport.com/methodology