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510(k) Data Aggregation

    K Number
    K013695
    Device Name
    MICROLINE INC. REUSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, MODEL M/L-10
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    2002-01-08

    (62 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To occlude and ligate vessels, ducts, tracts, and other tubular structures during Laparoscopic and general surgical procedures
    Device Description
    The Microline Reusable Laparoscopic Clip Applier with Implantable Titanium Surgical Clips is a reusable instrument designed for use with a disposable clip cartridge that is advanced inside the clip applier shaft. The rotatable clip applier shaft is sized to fit through a 10mm trocar. The Microline Reusable Laparoscopic Clip Applier is sold with a pre-loaded clip cartridge which contains 19 rectangular implantable titanium single-use surgical clips (width 5.4mm) that can be applied one at a time after firing. Cartidge loading is performed through a slot located in the rear of the instrument, in line with the instrument's shaft. Cartridge loading and unloading can be performed in-vivo without removing the Clip Applier from the trocar.
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    K Number
    K982984
    Device Name
    ACCUSHEAR LAPAROSCOPIC SURGICAL INSTRUMENTS
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1998-10-21

    (56 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures where instruments are introduced into the body through a cannula.
    Device Description
    The Microline ACCUSHEAR Laparoscopic Surgical Instruments are a line of nonsterile, reusable 5 mm diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula. The device is used with monopolar electrosurgical generators.
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    K Number
    K981389
    Device Name
    DISPOSABLE RE-NEW FORCEPS
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1998-05-29

    (43 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutting, Grasping, and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.
    Device Description
    The Disposable Re-New Forceps Laparoscopic Surgical Tips are an extension of the Re-New Forceps Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures. The Disposable Re-New Forceps Laparoscopic Surgical Tips consist of a series disposable tip configurations. Tip configurations include: Grasper, Fenestreded Forceps, "Dolphin Nose" Dissector, "Babcock", and "Maryland" Dissector.
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    K Number
    K981188
    Device Name
    ELECTROSURGICAL CAUTERY PROBES
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1998-05-20

    (48 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Microline reusable 3 mm and 5 mm diameter Electrosurgical Cautery Probes are intended to deliver energy from an independent monopolar electrosurgical generator to cauterize tissues during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
    Device Description
    The Microline Electrosurgical Cautery Probes are a line of non-sterile, reusable 3 mm and 5 mm diameter instruments used to deliver energy from an independent monopolar electrosurgical generator to cauterize tissue during laparoscopic (inclusive of endoscopic) surgical procedures where instruments are introduced into the body through a cannula.
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    K Number
    K980758
    Device Name
    3 MM SELEC-TIP LAPAROSCOPIC SCISSORS
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1998-03-27

    (28 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutting and Dissecting Various Abdominal Tissue during . Endoscopic (inclusive of laparoscopic) Surgical Procedures.
    Device Description
    The "3 MM Selec-Tip" Laparoscopic Surgical Instruments are a line of non-sterile, reusable small diameter instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The device can be used with monopolar electrosurgical generators.
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    K Number
    K974066
    Device Name
    RE-NEW FORCEPS LAPAROSCOPIC SURGICAL TIPS
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1998-01-22

    (87 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Re-New Forceps" Laparoscopic Surgical Tips are intended to cut, grasp, and dissect various abdominal issue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
    Device Description
    The "Re-New Forceps" Laparoscopic Surgical Tips are an extension of the "Re-New" Laparoscopic Instruments product line used to cut, grasp, and dissect various abdominal tissue during Endoscopic (inclusive of laparoscopic) surgical procedures. The "Re-New Forceps" Laparoscopic Surgical Tips consist of a series reusable tip configurations. The tip assembly, designed with a double thread, permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: - · Grasper, - · Fenestreded Forceps. - · "Dolphin Nose" Dissector, - · "Babcock", and - · "Maryland" Dissector
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    K Number
    K970826
    Device Name
    SELECTA-TIP LAPAROSCOPIC SCISSORS
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1997-03-28

    (22 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Selecta-Tip" Laparoscopic scissors tips are intended for use to cut and dissect various abdominal tissue in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula.
    Device Description
    The Selecta-Tip" Laparoscopic Scissors are surgical blades used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of reusable tips. The tip assembly is designed with a proprietary single thread and ball system, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Scissors tip configurations include: Metzenbaum, Mini, Hook, Endocut, and Micro.
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    K Number
    K962119
    Device Name
    RE-NEW LAPAROSCOPIC INSTRUMENTS
    Manufacturer
    MICROLINE PENTAX, INC.
    Date Cleared
    1996-08-09

    (70 days)

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

    MICROLINE PENTAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
    Device Description
    The Re-New" Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include : disposable tips, and reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: Metzenbaum, Mini, Hook, Endocut, and, Micro.
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