# K160795: United Urologics Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Robling Medical
- Decided: Jun 16, 2016 after 85 days
- Product code: GBM (Catheter, Urethral)
- 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 K992137 (1999). 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)
- K992137: Urological Catheter, Apogee, Inc. (1999) Summary page 4.

## Indications for use
United Urologics Intermittent Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

Source page: https://510kreport.com/device/K160795
Methodology: https://510kreport.com/methodology