BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE

    K Number: K130305 · Decision Jul 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    15
    Applicant Total
    16
    Review Days
    169

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
    K Number
    K130305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4150
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lina Medical Aps
    Date Received
    February 5, 2013
    Decision Date
    July 24, 2013
    Product Code
    HIN
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HIN), ordered by most recent decision date.

    PK Lap Loop

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    KSEA BIPOLAR ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PKS BILL

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TUBALGATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Lina Medical Aps

    K Number Device Name
    K240227 LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)
    K223932 SafeAir combi (SFR-combi-US)
    K221085 LiNA OperaScope Needle
    K193007 LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
    K182224 SafeAir Smoke Evacuator compact
    K182354 SafeAir Telescopic Smoke Pencil
    K171113 LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
    K143145 SafeAir Smoke Pencil
    K142757 LiNA PowerBlade Plus HC
    K142538 LiNA SafeAir Smoke Pencil
    Search all 16 clearances from Lina Medical Aps →