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FDA 510(k)

OMNITECH RESECTOSCOPE ROLLER ELECTRODE

K-Number: K965093 · 1997-03-19

ApplicantOmnitech Systems, Inc.
Decision Date1997-03-19
Product CodeFAS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OMNITECH RESECTOSCOPE ROLLER 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 1997-03-19 under 510(k) number K965093. 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 RESECTOSCOPE ROLLER ELECTRODE?

OMNITECH RESECTOSCOPE ROLLER ELECTRODE is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Omnitech Systems, Inc.. The 510(k) number is K965093.

When did OMNITECH RESECTOSCOPE ROLLER ELECTRODE receive FDA 510(k) clearance?

OMNITECH RESECTOSCOPE ROLLER ELECTRODE received FDA 510(k) clearance on 1997-03-19, under 510(k) number K965093.

Who is the listed applicant for OMNITECH RESECTOSCOPE ROLLER 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 RESECTOSCOPE ROLLER ELECTRODE?

The FDA product code for OMNITECH RESECTOSCOPE ROLLER ELECTRODE is FAS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Omnitech Systems, Inc. as applicant

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.

K151976Omnitech HF Resection Electrodes, Omnitech HF Vaporization ElectrodeK050454OMNITECH FULGURATING ELECTRODEK981463OMNITECH RESECTOSCOPE ROLLER ELECTRODEK981464OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODEK964365RESECTOSCOPE CUTTING LOOP ELECTRODE

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 ABK240504PLASMA EDGE SystemLamidey Noury MedicalK213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma EdgeChirurgie InnovationK210651Resection Electrodes with HF cableOlympus Winter & Ibe GmbHK210394Electrosurgical accessoryDornier Medtech America, Inc.

Official Source

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

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