510(k) Report

FDA applicant

Advanced Uroscience, Inc.

St. Paul, MN5 decisions1998–20010 recalls

FDA records 5 decisions for Advanced Uroscience, Inc. (St. Paul, MN) from 1998 to 2001: 5 510(k) clearances. Most are in product codes FBK (Endoscopic Injection Needle…) and GDW (Staple, Implantable). Its devices cite 4 predicates, 0 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Advanced Uroscience, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Advanced Uroscience, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FBKEndoscopic Injection Needle, Gastroenterology-Urology3decisions
  • GDWStaple, Implantable1decision
  • PAGMesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence…1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 19985cite it
  • K001807Tissue MarkerAdvanced Uroscience, Inc. · 20013cite it
  • K993459Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc. · 19993cite it
  • K002323Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 20001cites it

What has FDA decided for it lately?

  • K001807Tissue MarkerAdvanced Uroscience, Inc. · 2001
  • K002573Advanced Uroscience InnersheathAdvanced Uroscience, Inc. · 2000
  • K002323Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 2000
  • K993459Modification to Brennen Biosynthetic Surgical Mesh MatrixAdvanced Uroscience, Inc. · 1999
  • K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998

All 5 as Advanced Uroscience, Inc. →