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FDA 510(k)

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE

K-Number: K001270 · 2000-04-28

ApplicantGyrus Medical , Ltd.
Decision Date2000-04-28
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Medical , Ltd.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K001270. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE?

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Gyrus Medical , Ltd.. The 510(k) number is K001270.

When did GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE receive FDA 510(k) clearance?

GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE received FDA 510(k) clearance on 2000-04-28, under 510(k) number K001270.

Who is the listed applicant for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE?

The FDA 510(k) record lists Gyrus Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE?

The FDA product code for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE is FJL.

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Other records listing Gyrus Medical , Ltd. 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.

K041285GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)K003569PLASMAKINETIC ENDOUROLOGY SYSTEMK994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODEK993749GYRUS HYSTEROSCOPIC RESECTOSCOPEK990628GYRUS ENDOUROLOGY SYSTEMK982771GYRUS HYSTEROSCOPIC RESECTOSCOPE

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Related Devices (Code: FJL)

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.

K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KGK221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion SystemCorinth Medtech, Inc.K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc.K162979Veloxion SystemCorinth Medtech, 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.

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