# Omnitech Systems, Inc.

- Location (FDA's records): Valparaiso, IN
- FDA decisions: 6 (1997–2016): 6 510(k) clearances
- Product codes: FAS (4), KNF (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Dornier Medtech America Inc (Dmta): 1 (https://510kreport.com/company/dornier-medtech-america-dmta)
- Lina Medical Aps: 1 (https://510kreport.com/company/lina-medical)

## Its most-cited devices
- K151976: Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (2016), cited by 1
- K981464: Omnitech Resectoscope Cutting Loop Electrode (1998), cited by 1

## Recent decisions
- K151976: Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (Jun 27, 2016)
- K050454: Omnitech Fulgurating Electrode (May 27, 2005)
- K981463: Omnitech Resectoscope Roller Electrode (Jul 17, 1998)
- K981464: Omnitech Resectoscope Cutting Loop Electrode (Jul 10, 1998)
- K964365: Resectoscope Cutting Loop Electrode (Apr 22, 1997)
- K965093: Omnitech Resectoscope Roller Electrode (Mar 19, 1997)

Source page: https://510kreport.com/company/omnitech-systems
