# K970443: Hollister Retracted Penis Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Feb 25, 1997 after 20 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
Longest line of descent: 1 generation back to K862934 (1986). 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)
- K862934: Hollister Female Urinary Collection Pouch, Hollister, Inc. (1986) Summary page 1.

## Indications for use
The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis

Source page: https://510kreport.com/device/K970443
Methodology: https://510kreport.com/methodology