Search Filters

Search Results

Found 9 results

510(k) Data Aggregation

    K Number
    K142525
    Device Name
    PK Lap Loop
    Manufacturer
    Olympus Winter & Ibe GmbH
    Date Cleared
    2014-11-21

    (74 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bipolar Laparoscopic Loop is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Olympus Electrosurgical Generator ESG-400.
    Device Description
    The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Olympus Electrosurgical Generator ESG-400. It is available in an 88mm x 227mm loop size. The device is sterilized by ethylene.
    Ask a Question
    K Number
    K130305
    Device Name
    LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
    Manufacturer
    LINA MEDICAL APS
    Date Cleared
    2013-07-24

    (169 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LiNA Bipolar Loop is a 5mm bipolar electrosurgical device intended for amputating the mobilized uterus during laparoscopic supracervical (subtotal) hysterectomy and resection of devasculated subserosal pedunculated myomas. To be used with an electrosurgical generator that provides a bipolar outlet.
    Device Description
    The LiNA Bipolar Loop is a 5 mm single use laparoscopic instrument. It is available with three different loop dimensions; 160mm x 80mm, 200mm x 100mm x 120mm x 120mm. The outer 15mm on each side of the loop is not insulated i.e. the bipolar cutting area length totals 30mm. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet.
    Ask a Question
    K Number
    K122983
    Device Name
    KSEA BIPOLAR ELECTRODE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2013-06-26

    (273 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Bipolar Electrode is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions and septa, and benign conditions requiring endometrial ablation. Procedures include: Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa Endometrial ablation
    Device Description
    The Karl Storz Bipolar Electrode is a single-use.cutting loop electrode that is designed to be used in combination with a 4 mm resectoscope with a 24 or 26 Fr sheath that is connected to a generator via a high frequency cable.
    Ask a Question
    K Number
    K122605
    Device Name
    PKS BILL
    Manufacturer
    GYRUS ACMI, INC.
    Date Cleared
    2012-12-05

    (100 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
    Device Description
    The Bipolar Laparoscopic Loop is a single use disposable high frequency RF bipolar accessory to be used in conjunction with the G400 generator. It is available in an 88mm x 227mm loop size. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10-6.
    Ask a Question
    K Number
    K113080
    Device Name
    TUBALGATOR
    Manufacturer
    MECTRA LABS, INC.
    Date Cleared
    2012-06-29

    (255 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K111751
    Device Name
    VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
    Manufacturer
    ETHICON, INC.
    Date Cleared
    2011-12-02

    (163 days)

    Product Code
    HIN, HIH
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. Procedures include: - . Excision of intrauterine myomas - ◆ Excision of intrauterine polyps - . Lysis of intrauterine adhesions - Incision of uterine septa - . Endometrial ablation
    Device Description
    The GYNECARE VERSAPOINT™ II Bipolar Electrosurgery System (VERSAPOINT II System) is the next generation of the currently-marketed GYNECARE VERSAPOINT™ Bipolar Electrosurgery System (VERSAPOINT System). This electrosurgical system utilizes bipolar technology specifically designed to provide a range of gynecological surgical treatments, including vaporization to ablate and excise tissue, thermal coagulation of tissue and hemostasis of blood vessels. The VERSAPOINT II System is comprised of four main elements: the VERSAPOINT II Generator, the VERSAPOINT II 4mm Angled Loop Electrode, the VERSAPOINT II Footswitch, and the VERSAPOINT II Connector Cable. The VERSAPOINT II System offers five bipolar output modes: Ablation (VC [VaporCut]) – for tissue removal and cutting Enhanced Ablation (VP [VersaPulse]) - an enhanced version of the Ablation (VC) output mode attained by use of short-duration high power pulses Blended Ablation (BL) – simultaneous ablation and coagulation (the generator rapidly switches between ablation and coagulation output modes) Enhanced Blended Ablation (VBL) – a variant of the VP output mode that rapidly switches the output ON and OFF to deliver blended ablation/coagulation Coagulation (DES [Desiccate]) - for thermal coagulation and hemostasis
    Ask a Question
    K Number
    K111059
    Device Name
    GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
    Manufacturer
    GYRUS ACMI, INC.
    Date Cleared
    2011-09-01

    (136 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation/sectioning of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.
    Device Description
    The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0
    Ask a Question
    K Number
    K990147
    Device Name
    BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    1999-04-16

    (87 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The coagulation of tubes, tissue coagulation and vascular coagulation, and to stop bleedings under endoscopic vision, including coagulation of the fallopian tube and the mesoalpinx for female sterilization.
    Device Description
    The modular bipolar forcep set provides precise grasping and axial holding placement of the jaws, performs thorough hygiene, and site irrigation can be achieved without using additional instruments.
    Ask a Question
    K Number
    K971565
    Device Name
    BICOAG COAGULATING FORCEPS
    Manufacturer
    EVEREST MEDICAL CORP.
    Date Cleared
    1998-03-12

    (317 days)

    Product Code
    HIN
    Regulation Number
    884.4150
    Why did this record match?
    Product Code :

    HIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.
    Device Description
    The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.
    Ask a Question

    Page 1 of 1