510(k) Report

FDA applicant

Uromedica, Inc.

Plymouth1 decision2015–20152 recalls

FDA records 1 decision for Uromedica, Inc. (Plymouth) in 2015: 1 original PMA approval. All are in product code EZY (Device, Incontinence, Mechanical/Hydraulic). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Uromedica, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2021

2019: 12021: 1
2015high 1 (2019) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Uromedica, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EZYDevice, Incontinence, Mechanical/Hydraulic1decision

What has FDA decided for it lately?

  • P130018Proact Adjustable Continence Therapy for MenUromedica, Inc. · 20152 recalls

The one decision as Uromedica, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P130018UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.Nov 22, 2021Class II
  • P130018ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical…Apr 10, 2019Class II