# K963950: Bioderm Eid Male External Incontinence Device

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm, Inc.
- Decided: Jan 10, 1997 after 100 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. The FDA summary names its predicate without a number.
- (no number) Hollister PolyTech™, non-latex, self-adhesive urinary external catheter: named in the summary without a submission number

## Indications for use
The BioDerm® EID® is an external male catheter intended for the management of urinary incontinence in males. It facilitates urine drainage into a urine collection bag,

Source page: https://510kreport.com/device/K963950
Methodology: https://510kreport.com/methodology