Omnitech Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Omnitech Systems, Inc. makes
Omnitech Systems, Inc. manufactures electrodes and resectoscopes designed for high-frequency (HF) tissue resection and vaporization procedures, including fulgurating electrodes, cutting loop electrodes, and roller electrodes for use in resectoscopes.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Omnitech Fulgurating Electrode Ref K050454
Regimes: 510(k) Registry: 510(k)Omnitech Resectoscope Cutting Loop Electrode Ref K981464
Regimes: 510(k) Registry: 510(k)Omnitech Resectoscope Roller Electrode Ref K965093
Regimes: 510(k) Registry: 510(k)Omnitech Resectoscope Roller Electrode Ref K981463
Regimes: 510(k) Registry: 510(k)Resectoscope Cutting Loop Electrode Ref K964365
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omnitech Systems, Inc. have in the registry?
The registry currently lists 6 devices for Omnitech Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnitech Systems, Inc.'s devices?
Among its 6 most recently registered devices, Omnitech Systems, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Omnitech Systems, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Omnitech Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omnitech Systems, Inc. in the registry?
The most recently registered devices listed for Omnitech Systems, Inc. include OMNITECH FULGURATING ELECTRODE, OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE, OMNITECH RESECTOSCOPE ROLLER ELECTRODE and RESECTOSCOPE CUTTING LOOP ELECTRODE.