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FDA 510(k)

GENICON SUCTION IRRIGATION SYSTEM

K-Number: K041967 · 2004-11-12

ApplicantGenicon
Decision Date2004-11-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GENICON SUCTION IRRIGATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genicon. It received FDA 510(k) clearance on 2004-11-12 under 510(k) number K041967. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENICON SUCTION IRRIGATION SYSTEM?

GENICON SUCTION IRRIGATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-12. The listed applicant is Genicon. The 510(k) number is K041967.

When did GENICON SUCTION IRRIGATION SYSTEM receive FDA 510(k) clearance?

GENICON SUCTION IRRIGATION SYSTEM received FDA 510(k) clearance on 2004-11-12, under 510(k) number K041967.

Who is the listed applicant for GENICON SUCTION IRRIGATION SYSTEM?

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

What is the FDA product code for GENICON SUCTION IRRIGATION SYSTEM?

The FDA product code for GENICON SUCTION IRRIGATION SYSTEM is GCJ.

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.

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Other records listing Genicon 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.

K100090IMPLANTABLE CLIPK061417GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910K041968GENICON BIPOLAR FORCEPS MODEL # 600-005-005

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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