# K181346: CystoSure Plus Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Emmy Medical, LLC
- Decided: Aug 6, 2018 after 77 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
Longest line of descent: 2 generations back to K040390 (2004). 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)
- K142194: CytoSure Urinary Access System, Emmy Medical (2014) Summary page 4.

## Indications for use
The CystoSure® Plus catheter provides access and visualization for the female urinary bladder. The single-use CystoSure® Plus catheter provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of an endoscope. It is suitable for medium- to long-term use with a maximum patient indwelling time < 30 days.

Source page: https://510kreport.com/device/K181346
Methodology: https://510kreport.com/methodology