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FDA 510(k)

OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE

K-Number: K981464 · 1998-07-10

ApplicantOmnitech Systems, Inc.
Decision Date1998-07-10
Product CodeKNF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OMNITECH RESECTOSCOPE CUTTING LOOP 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 1998-07-10 under 510(k) number K981464. The device is classified under product code KNF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE?

OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Omnitech Systems, Inc.. The 510(k) number is K981464.

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

OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE received FDA 510(k) clearance on 1998-07-10, under 510(k) number K981464.

Who is the listed applicant for OMNITECH RESECTOSCOPE CUTTING LOOP 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 CUTTING LOOP ELECTRODE?

The FDA product code for OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE is KNF.

Related Clinical Trials

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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 ELECTRODEK964365RESECTOSCOPE CUTTING LOOP ELECTRODEK965093OMNITECH RESECTOSCOPE ROLLER ELECTRODE

Related Devices (Code: KNF)

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.

K254303KARL STORZ SUPRALOOPKarl Storz SE & CO. KGK250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc.K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc.

Official Source

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