# K970308: Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Urology, Inc.
- Decided: Apr 2, 1997 after 65 days
- Product code: FHA (Clamp, Penile)
- Device class: 1
- Regulation: 21 CFR 876.5160
- 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K884426: Bard Cunningham Incontinence Clamp. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Mentor Urology Triple Rib Occlusion Wrap for Male Incontinence is indicated for any male, who has urinary incontinence, either on a temporary or long term basis. It is also indicated for those patients who have an adverse reaction to natural latex rubber.

Source page: https://510kreport.com/device/K970308
Methodology: https://510kreport.com/methodology