# K142194: CytoSure Urinary Access System

- Pathway: 510(k) (Traditional)
- Applicant: Emmy Medical
- Decided: Dec 19, 2014 after 130 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040390 (2004). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040390: Stryker Urology and Gynecology Hardware System, Stryker Endoscopy (2004) Summary page 4.

## Most influential descendants
- K181346: CystoSure Plus Catheter (2018), 0 descendants of its own
- K172422: Kohli Urinary Drainage Catheter (2018), 0 descendants of its own

## Indications for use
The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder. The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.

Source page: https://510kreport.com/device/K142194
Methodology: https://510kreport.com/methodology