# K013141: Microgyn Plus Stimulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Hollister, Inc.
- Decided: Dec 19, 2001 after 90 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K891773 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963222: Microgyn Plus Stimulation Device, Hollister, Inc. (1996) Summary page 1.
- K964738: Elpha 2000 Conti, Dan Med, Inc. (1997) Summary page 1.

## Indications for use
The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

Source page: https://510kreport.com/device/K013141
Methodology: https://510kreport.com/methodology