# K971499: Female External Urinary Collection Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Mediquest, Inc.
- Decided: Aug 28, 1997 after 125 days
- Product code: EXI (Device, Paste-On For Incontinence, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
As a disposable, single use Female External Urinary Collection Pouch, it is intended to collect urine and assist in directing it away from the body.

Source page: https://510kreport.com/device/K971499
Methodology: https://510kreport.com/methodology