510(k) Report

FDA applicant

Urothealth System, Inc.

Richland, MI1 decision1998–19980 recalls

FDA records 1 decision for Urothealth System, Inc. (Richland, MI) in 1998: 1 510(k) clearance. All are in product code KNW (Instrument, Biopsy). 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 Urothealth System, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Urothealth System, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Urothealth System, 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?

  • KNWInstrument, Biopsy1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K972328Percutaneous Breast Biopsy (PBB)Urothealth System, Inc. · 19981cites it

What has FDA decided for it lately?

  • K972328Percutaneous Breast Biopsy (PBB)Urothealth System, Inc. · 1998

The one decision as Urothealth System, Inc. →