# K082831: Amself Closed Catheterization System

- Pathway: 510(k) (Special)
- Applicant: Amsino International, Inc.
- Decided: Oct 23, 2008 after 27 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 K030712 (2003). 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)
- K030712: Amsure Urethral Catheterization Tray, Amsino International, Inc. (2003) Summary page 1.

## Indications for use
The AMSelf m Closed Catheterization System is intended for use in the drainage of urine from the bladder.

Source page: https://510kreport.com/device/K082831
Methodology: https://510kreport.com/methodology