# K961906: Uni-Gard Quik Cath (Sizes 8 French Through 18)UG 10008,10010,10012,10014,10016,10018

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medsystems Corp.
- Decided: Nov 19, 1996 after 187 days
- Product code: EYZ (System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile)
- Device class: 1
- Regulation: 21 CFR 876.5250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® Touchless® Plus Unisex Intermittent Catheter: named in the summary without a submission number
- (no number) MMG/O'Neil® Sterile Field Urinary Intermittent Catheter System: named in the summary without a submission number

## Indications for use
The UNI-GARD QUIK CATH™ is indicated for use to drain urine from the bladder and collect the urine from the bladder in a bag. The UNI-GARD QUIK CATH™ is a unisex intermittent unitized catheter system.

Source page: https://510kreport.com/device/K961906
Methodology: https://510kreport.com/methodology