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510(k) Data Aggregation

    K Number
    K090796
    Device Name
    MULTI-BITE HOT BIOPSY FORCEPS
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2009-11-25

    (246 days)

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

    ENDO-THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biopsy forceps are intended for use in collecting tissue samples for histological examination.
    Device Description
    Multi-bite Electric (Hot) Biopsy Forceps
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    K Number
    K031026
    Device Name
    ETI BIPOLAR HEMOSTATIC PROBE
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2003-06-27

    (88 days)

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

    ENDO-THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ETI Hemostatic Probe is intended for use during endoscopic procedures where electrosurgery is required to cauterize tissue of actual or potentially bleeding sites in the gastrointestinal tract. The device also can be used for irrigation.
    Device Description
    Not Found
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    K Number
    K023603
    Device Name
    ENDO-GLIDE GUIDEWIRE
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2003-02-19

    (114 days)

    Product Code
    OCY, GCA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO-THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endo-Glide Guidewires are intended to be used for selective cannulization of the biliary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic biliary procedures for catheter introduction and exchanges.
    Device Description
    The Endo-Glide Guidewire has a range of diameters from 0.025" to 0.035" and lengths from 250cm to 450cm. The wires are offered with and without a 50mm radiopaque platinum distal tip (curved and straight). The wires are assembled with a solid nitinol or stainless steel core wire, which can be tapered at the distal tip. A lubricious coating (PTFE or hydrophilic) surrounds the entire core and/or tip, which also provides insulation.
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    K Number
    K012725
    Device Name
    TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2001-11-08

    (85 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO-THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endo-Therapeutics Laparoscopic Surgical Instruments are a line of reusable general surgical forceps, graspers and scissors intended to be used for lifting, dissecting, cutting organs and tissue during general open and laparoscopic procedures.
    Device Description
    Not Found
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    K Number
    K012977
    Device Name
    VARICES INJECTION NEEDLE
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Date Cleared
    2001-11-02

    (58 days)

    Product Code
    FBK
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO-THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Varices Injection Needles are used for endoscopic injection of legally marked sclerotherapy agent and dyes into esophageal or colonic varices
    Device Description
    Not Found
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