# P130018: Proact Adjustable Continence Therapy for Men

- Pathway: PMA
- Applicant: Uromedica, Inc.
- Decided: Nov 24, 2015 after 890 days
- Product code: EZY (Device, Incontinence, Mechanical/Hydraulic)
- Device class: 3
- Regulation: 21 CFR 876.5280
- Recalls of this device: 2 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 22, 2021 · Class II · Z-0458-2022: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
- Apr 10, 2019 · Class II · Z-1808-2020: Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when 

Source page: https://510kreport.com/device/P130018
Methodology: https://510kreport.com/methodology