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510(k) Data Aggregation

    K Number
    K221524
    Device Name
    Sugita AVM Microclip Applier
    Manufacturer
    Mizuho America, Inc.
    Date Cleared
    2022-06-24

    (29 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sugita AVM Microclip Applier is exclusively designed to place Sugita AVM Microclips during surgical procedures.
    Device Description
    The Sugita AVM Microclip Applier has a spring handle design with a ratchet. The Sugita AVM Microclip Applier serves to open and close the Sugita AVM Microclips. Using the Sugita AVM Microclip Applier, the Sugita AVM Microclips are removed from their packaging and applied, repositioned or removed from the target tissue. The Sugita AVM Microclip Applier has no function of its own and may only be used in combination with the Sugita AVM Microclips. The Sugita AVM Microclip Applier has the same design and materials as the clip applier in the K960037. The body of the Sugita AVM Microclip Applier is manufactured from stainless steel and the jaws are manufactured from Elgiloy, a cobalt-chromium-molybdenum alloy.
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    K Number
    K211572
    Device Name
    Aesculap Slim Clip Applier
    Manufacturer
    Aesculap, Inc
    Date Cleared
    2021-12-13

    (206 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.
    Device Description
    The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
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    K Number
    K180914
    Device Name
    Aesculap Slim Clip Applier
    Manufacturer
    Aesculap, Inc.
    Date Cleared
    2018-04-17

    (8 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap Slip Clip Applier forceps are used for opening, closing, and applying Aesculap Y ASARGIL aneurysm clips.
    Device Description
    The Aesculap Slim Clip Appliers are manufactured from stainless steel (body & jaw). The previously cleared appliers are available in lengths ranging from 50 mm to 110 mm in 10 mm increments. In addition to the straight jaw configuration (0%), the Clip Appliers are available with jaws angled up & down (5° to 15°), left & right (5° to 15°), in increments of 5° in all lengths. This submission intends to add additional lengths of 120 mm and 130 mm in these configurations. This submission intends to add additional jaw angulations of 20° to 45° up and down and 20° to 30° left and right in 5° increments and lengths ranging from 50-130 mm in 10 mm increments. In addition to these configurations, clip appliers with latches will be available in lengths ranging from 70 mm to 110 mm increments with jaw angulations ranging from straight, 5° to 45° up and down and 5° to 30° left and right in 5° increments. Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.
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    K Number
    K173271
    Device Name
    Aesculap Slim Clip Applier Forceps
    Manufacturer
    Aesculap, Inc.
    Date Cleared
    2017-11-10

    (29 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap Slim Clip Applier forceps are used for opening, closing, and applying Aesculap YASARGIL aneurysm clips.
    Device Description
    The Aesculap Slim Clip Applier forceps are manufactured from stainless steel (body & jaw). The appliers are available in lengths ranging from 50 mm to 110 mm. In addition to the straight jaw configuration, the Clip Appliers are available with jaws angled up & down, left & right. Each Clip Applier is individually laser marked with the type of clip designated for use. In addition, identification plugs to easily identify each clip designation are placed in the handles.
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    K Number
    K010910
    Device Name
    MEDICON YASARGIL CLIP APPLYING FORCEPS
    Manufacturer
    MEDICON, E.G.
    Date Cleared
    2001-08-01

    (128 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994191
    Device Name
    SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
    Manufacturer
    NMT MEDICAL, INC.
    Date Cleared
    2000-02-08

    (57 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for and intended use of the aneurysm clip applier is to hold and sufficiently open the aneurysm clip for application during intracranial aneurysm repair surgery. The device is used to deliver the aneurysm clip to the site of the intracranial aneurysm. The Spetzler™ Round-Handled Applier is designed for use only with the Spetzler™ Titanium Aneurysm Clips.
    Device Description
    There are two types of Spetzler™ Round Handle Appliers; Stainless Steel with Titanium Jaws and Pads and completely Titanium. Each type applier has two styles; straight and bayonet.
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    K Number
    K984109
    Device Name
    AESCULAP AXIAL CLIP APPLIER
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    1999-02-12

    (87 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aesculap Axial Clip Appliers are used for holding and applying intracranial aneurysm clips.
    Device Description
    There are twelve Axial clip appliers; each with complete material and design compatibility with Aesculap's existing Yasargil titanium and phynox aneurysm clip patterns. The new Axial clip appliers are available in three lengths (70mm, 90mm, 110mm), two jaw sizes (mini and standard), and two jaw materials (phynox and titanium).
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    K Number
    K982379
    Device Name
    SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
    Manufacturer
    JOHNSON & JOHNSON PROFESSIONALS, INC.
    Date Cleared
    1998-12-18

    (163 days)

    Product Code
    HCI, SUN
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sundt Slim-Line Aneurysm Clip Applier is designed for use only with Sundt Slim-Line Aneurysm Clips.
    Device Description
    The subject Sundt Slim-Line Aneurysm Clip Applier is a stainless steel reusable hand-held instrument that is available in two configurations a fixed tip applier and a hinged tip applier. All three appliers consist of a handle grip with serrations, a two-piece spring, a shaft, and a v-grooved shape tip for grasping the aneurysm clip. The fixed tip Sundt Slim-Line Aneurysm Clip Applier and the Sugita appliers are designed with shaft that angles down and a thin tip profile to provide the surgeon a greater field of view during clip placement.
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    K Number
    K954658
    Device Name
    PERNECZKY CLIP APPLIER/REMOVER
    Manufacturer
    VON ZEPPELIN GMBH
    Date Cleared
    1996-10-08

    (364 days)

    Product Code
    HCI
    Regulation Number
    882.4175
    Why did this record match?
    Product Code :

    HCI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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