FDA 510(k)

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

K-Number: K151976 · 2016-06-27

Decision Date2016-06-27

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Omnitech Systems, Inc.. It received FDA 510(k) clearance on 2016-06-27 under 510(k) number K151976. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is a medical device that received FDA 510(k) clearance on 2016-06-27. The listed applicant is Omnitech Systems, Inc.. The 510(k) number is K151976.

When did Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode receive FDA 510(k) clearance?

Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode received FDA 510(k) clearance on 2016-06-27, under 510(k) number K151976.

Who is the listed applicant for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA 510(k) record lists Omnitech Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode?

The FDA product code for Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode is FAS.

Related Devices (Code: FAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251403Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc )Dornier Medtech America Inc (Dmta)K250522Multi4 SystemMulti4 Medical AB K240504PLASMA EDGE SystemLamidey Noury Medical K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie Innovation K210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbH K210394Electrosurgical accessoryDornier Medtech America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.