510(k) Report

FDA applicant

Urocure, LLC

Minneapolis, MN3 decisions2019–20220 recalls

FDA records 3 decisions for Urocure, LLC (Minneapolis, MN) from 2019 to 2022: 3 510(k) clearances. All are in product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For…). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

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

FDA decisions per year

2in 2022

2019: 12022: 2
2019high 2 (2022) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Urocure, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic…3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K183134ArcTV Transvaginal Sling SystemUrocure, LLC · 20192cite it

What has FDA decided for it lately?

  • K222293ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
  • K222468ArcTO Transobturator Sling SystemUrocure, LLC · 2022
  • K183134ArcTV Transvaginal Sling SystemUrocure, LLC · 2019

All 3 as Urocure, LLC →