510(k) K151976

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode by Omnitech Systems, Inc. — Product Code FAS

K151976 is an FDA 510(k) premarket notification submitted by Omnitech Systems, Inc. for the device "Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode". The FDA issued a decision of Substantially Equivalent on June 27, 2016. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Omnitech Systems, Inc. has at least 5 other 510(k) clearances on record.