# K070939: Self-Cath CS Closed Urinary Catheterization System

- Pathway: 510(k) (Special)
- Applicant: Coloplast Manufacturing Us, LLC
- Decided: Jun 1, 2007 after 58 days
- Product code: FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit))
- 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: 1 generation back to K003873 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003873: Mentor Self-Cath Closed System, Mentor Corp. (2001) Summary page 2.

## Indications for use
Self-Cath® CS Closed System is intended for use in male or female patients needing bladder drainage as determined by their physician. More specifically it is intended for use where drainage of the bladder into a suitable receptacle such as a commode or bedpan is not feasible or practical. The device can be used by either the patient, once appropriate training has taken place, or by a trained health care professional.

Source page: https://510kreport.com/device/K070939
Methodology: https://510kreport.com/methodology