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FDA 510(k)

GYRUS ENDOUROLOGY SYSTEM

K-Number: K990628 · 1999-06-29

ApplicantGyrus Medical , Ltd.
Decision Date1999-06-29
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GYRUS ENDOUROLOGY SYSTEM 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 1999-06-29 under 510(k) number K990628. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ENDOUROLOGY SYSTEM?

GYRUS ENDOUROLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is Gyrus Medical , Ltd.. The 510(k) number is K990628.

When did GYRUS ENDOUROLOGY SYSTEM receive FDA 510(k) clearance?

GYRUS ENDOUROLOGY SYSTEM received FDA 510(k) clearance on 1999-06-29, under 510(k) number K990628.

Who is the listed applicant for GYRUS ENDOUROLOGY SYSTEM?

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?

The FDA product code for GYRUS ENDOUROLOGY SYSTEM is KNS.

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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 SYSTEMK001270GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODEK994166GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODEK993749GYRUS HYSTEROSCOPIC RESECTOSCOPEK982771GYRUS HYSTEROSCOPIC RESECTOSCOPE

View all 8 devices →

Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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