510(k) Report

FDA applicant

Omnitech Systems, Inc.

Valparaiso, IN6 decisions1997–20160 recalls

FDA records 6 decisions for Omnitech Systems, Inc. (Valparaiso, IN) from 1997 to 2016: 6 510(k) clearances. Most are in product codes FAS (Electrode, Electrosurgical, Active, Urological) and KNF (Coagulator-Cutter, Endoscopic, Unipolar (And…). 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 Omnitech Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Omnitech Systems, 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?

  • FASElectrode, Electrosurgical, Active, Urological4decisions
  • KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)2decisions

Who builds on its devices?

Later devices cite its devices 2 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.

  • K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc. · 20161cites it
  • K981464Omnitech Resectoscope Cutting Loop ElectrodeOmnitech Systems, Inc. · 19981cites it

What has FDA decided for it lately?

  • K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeOmnitech Systems, Inc. · 2016
  • K050454Omnitech Fulgurating ElectrodeOmnitech Systems, Inc. · 2005
  • K981463Omnitech Resectoscope Roller ElectrodeOmnitech Systems, Inc. · 1998
  • K981464Omnitech Resectoscope Cutting Loop ElectrodeOmnitech Systems, Inc. · 1998
  • K964365Resectoscope Cutting Loop ElectrodeOmnitech Systems, Inc. · 1997
  • K965093Omnitech Resectoscope Roller ElectrodeOmnitech Systems, Inc. · 1997

All 6 as Omnitech Systems, Inc. →