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510(k) Data Aggregation

    K Number
    K992544
    Device Name
    TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
    Manufacturer
    CIRCON CORP.
    Date Cleared
    1999-10-26

    (88 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Circon's Rigid Operative Culdoscopy Accessories are intended to be used with Circon's Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs. Indications for use are: - Unexplained pelvic pain (acute, chronic) - Menstrual abnormalities - Infertility and sterility - Indefinite pelvic mass - Ectopic pregnancy - Pelvic endometriosis - Polycystic ovaries - Pelvic inflammatory disease (PID) - Pain mapping - Congenital anomalies of the pelvic organs - Lysis of adhesions - Cytology sampling - Biopsy
    Device Description
    Circon's Rigid Operative Culdoscopy Accessories consist of several tubular stainless steel components. During culdoscopy, light from a high intensity light source is transmitted to a rigid culdoscope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the evepiece, or the scope may be connected to a video system via a standard endoscopic video coupler. In order to perform operative procedures, the operative cannula of the subject system replaces the smaller diagnostic cannula of the predicate system, and an operative sheath replaces the smaller diagnostic sheath of the predicate system. A channel is formed between the culdoscope and the operative sheath, thereby allowing passage of small instruments for a variety of operative procedures.
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    K Number
    K992126
    Device Name
    CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM
    Manufacturer
    CIRCON CORP.
    Date Cleared
    1999-08-03

    (41 days)

    Product Code
    GCX
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Circon Corporation's Tsunami™ Battery-Powered Irrigation Pump is intended to be used in conjunction with Circon's Surgiflex® WAVE® Tsunami™ Suction-Irrigation System to provide controlled, powered delivery of sterile irrigation fluids to surgical sites and to evacuate blood, tissue debris and smoke from the operative field to aid in visualization during laparoscopic and open surgical procedures. The system may also be used for resection of filmy adhesions and for peritoneal lavage.
    Device Description
    The Circon Surgiflex® WAVE® Tsunami™ Suction-Irrigation System is comprised of a Tsunami™ Battery-Powered Pump that may be attached to a source of irrigation tubing connected to a Surgiflex WAVE suction-irrigation handpiece, and a length of suction tubing connected between the handpiece and a vacuum source (usually a suction canister that is connected to a wall suction outlet). Irrigation solution is introduced to the surgical site and fluids, debris and smoke are evacuated from the site via a disposable suction-irrigation probe. All components of the system are supplied sterile, disposable in a sealed plastic tray for single patient use.
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    K Number
    K981611
    Device Name
    SNAP-N-PEEL INTRODUCERS
    Manufacturer
    CIRCON CORP.
    Date Cleared
    1998-07-30

    (85 days)

    Product Code
    KNY
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CIRCON SURGITEK's Snap-N-Pee!™ Introducers are intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g., nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.
    Device Description
    The CIRCON SURGITEK Snap-N-Peel7M Introducer consists of a stepped dilator (with proximal Luer hub) that fits within an external sheath (with rotating locking collar). The dilator may be straight or curved and has a lumen to allow passage of fluids or a guidewire.
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    K Number
    K980972
    Device Name
    RIGID CULDOSCOPE AND ACCESSORIES
    Manufacturer
    CIRCON CORP.
    Date Cleared
    1998-06-12

    (88 days)

    Product Code
    HEW
    Regulation Number
    884.1640
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: Unexplained pelvic pain (acute, chronic), Menstrual abnormalities, Infertility and sterility, Indefinite pelvic mass, Ectopic pregnancy, Pelvic endometriosis, Polycystic ovaries, Pelvic inflammatory disease, Pain mapping, Congenital anomalies of the pelvic organs.
    Device Description
    CIRCON's Rigid Culdoscopes and Accessories are rod lens-type endoscopes which consist of imaging optics and fiber optic illumination fibers contained within a stainless steel sleeve. Light from a high intensity light source is transmitted to the scope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
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    K Number
    K973820
    Device Name
    USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
    Manufacturer
    CIRCON CORP.
    Date Cleared
    1998-05-12

    (217 days)

    Product Code
    FAS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Circon ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome Resection Electrodes are indicated for use in urology for cutting, coagulation, and vaporization of soft tissue, including prostatic and bladder tissue and the treatment of benign prostatic hyperplasia (BPH) and bladder cancer.
    Device Description
    CIRCON ACMI's USA Elite System™ VaporTrode™ Vaporization Electrodes and VaporTome™ Resection Electrodes are electrosurgical electrodes used in CIRCON ACMI's resectoscopes utilizing a direct connection between the electrode and the active cord of the electrosurgical generator.
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    K Number
    K964594
    Device Name
    VAPORTRODE VAPORIZATION ELECTRODE -GROOVED/FLUTED/SPIKED(GVE-B,GVE-F,GVE-S) & VAPORTOMME VAPORIZATION LOOP (GVE-LG)
    Manufacturer
    CIRCON CORP.
    Date Cleared
    1997-08-15

    (273 days)

    Product Code
    KNF
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    CIRCON CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The primary indications for use are abnormal uterine bleeding with or without pain, and infertility. Vaporization electrodes intended uses in gynecology, along with other resectoscopic electrodes and instruments, are: transuterine resection of fibroids, endometrial ablation, resectoscopic management of Müllerian fusion defects, resectoscopic management of intrauterine lesions, resectoscopic management of intractable uterine bleeding.
    Device Description
    VaporTrode™ Vaporization Electrodes in Gynecology
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