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510(k) Data Aggregation

    K Number
    K251054
    Device Name
    Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
    Manufacturer
    Teleflex Medical
    Date Cleared
    2025-07-03

    (90 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242541
    Device Name
    GEM ZIPCLIP
    Manufacturer
    Synovis Micro Companies Alliance A subsidiary of Baxter Int
    Date Cleared
    2025-01-15

    (142 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.
    Device Description
    The GEM ZIPCLIP (ZIPCLIP) is a sterile, single-use automatic microclip applier. Each device contains 15 titanium microclips. When applied on a vessel, microclips remain with the patient as permanent implants. ZIPCLIP is for prescription use only and the use environment is the operating room. The ZIPCLIP device is a pre-loaded, disposable, single-patient use mechanical assembly comprised of plastic and metal components. The applier device has (2) scissor-like handles that, when driven medially, close the distal jaws forming a closed clip the device in the open configuration. When released, the handles return to their resting state and the closed clip disengages from the applier. Simultaneously, a new clip is automatically loaded into the distal jaws for consecutive firing. When ZIPCLIP is empty a lockout clip (anodized gold in color) deploys between the jaws, preventing them from closing. The ZIPCLIP is a mechanical assembly comprised of plastic and metal components. The clips are composed exclusively of titanium (Grade 1) and are supplied sterile in a preloaded channel that is incorporated into the number of clips per applier is fifteen (15). The clips are stacked and contained internal to the device. Clips cannot be reloaded once the stack is deployed and the applier is disposed of once emptied. Note, the ZIPCLIP preloaded microclips that can be used with the ZIPCLP device.
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    K Number
    K221495
    Device Name
    SOLID CLIP™ Single Use Clip Applier
    Manufacturer
    Medscope Biotech Co., Ltd.
    Date Cleared
    2024-07-18

    (787 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.
    Device Description
    The SOLID CLIP™ Single Use Clip Applier is a sterile, single patient use device designed for an appropriately sized trocar sleeve or larger sized trocar sleeve with the use of a converter. It consists of a shaft with an outer diameter of 10 or 5 mm and length of 33 cm, a jaw for forming ligating clips, a pistol handle, an actuation trigger, a 360 degrees rotational knob, and a clip counter. The shaft with outer diameter 10 mm was preloaded 10, 15, 20 ML (Medium-Large) or 10, 15 L (Large) titanium clips, outer diameter 5 mm shaft only preloaded 10, 15 ML (Medium-Large) titanium clips. Squeezing the trigger places a titanium clip in the jaws and closes the jaws to form the clip on the occlusion of the vessel or tubular structure. The design of SOLID CLIP™ Single Use Clip Applier provides secured placement of the clip to the targeted vessel and enables the surgeon to apply the clips during a laparoscopic procedure without the need for withdrawing and reinserting the device each time a clip is put in place and closed.
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    K Number
    K232970
    Device Name
    Hem-o-lok® Ligating Clips
    Manufacturer
    Teleflex Medical
    Date Cleared
    2024-01-12

    (113 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hem-o-lok® Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    Hem-o-lok® Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are available in four sizes (Medium, Medium-Large, Large, Extra Large), allowing the end user to ligate a wide range of vessels and tissue structures. Hem-o-lok® Ligating Clips are manufactured from a non-absorbable acetyl polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices. Accessories to the Hem-o-lok® Ligating Clips include manual clip appliers and removers for use in both general open and endoscopic procedures. Both the appliers and removers are multiple use, non-sterile devices that require cleaning and sterilization prior to each use.
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    K Number
    K230966
    Device Name
    angiOCCLUDE Ligating Clips
    Manufacturer
    A2 Medical Systems, LLC
    Date Cleared
    2023-09-19

    (167 days)

    Product Code
    FZP, DSS
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    angiOCCLUDE ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of vessel or tissue structure to be ligated based upon their experience, judgment, and needs.
    Device Description
    AngiOCCLUDE ligating clips are permanent implant, non-absorbable, sterile, surgical clips made from an implantable grade of Titanium and are available in six different sizes (micro, small-wide, medium, medium-large and large).
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    K Number
    K232313
    Device Name
    LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
    Manufacturer
    Ethicon Endo Surgery, LLC.
    Date Cleared
    2023-08-29

    (27 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIGACLIP Endoscopic Rotating Multiple Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated. The tissue being ligated should be consistent with the size of the clip.
    Device Description
    The LIGACLIP 12mm L and 10mm M/L Endoscopic Rotating Clip Appliers are sterile, single-patient use instruments designed to provide a means of ligation through surgical trocars. The instruments deliver titanium clips that individually advance after each firing. The shafts of these devices are made of a low glare material that minimizes reflective distortion. The are designed to rotate 360 degrees in either direction. The configuration of the Subject devices, Ligaclip® 12mm Land 10mm M/L Endoscopic Rotating Multiple Clip Appliers consist of a pistion knob, and a shaft. The shaft is made of a low glare material that mininizes reflective distal end of the shaft are the jaws, which form ligating dips. The force to squeeze the trigger increases when no clips remain in the device. The shaft contains a yellow clip counter indicator bar, which appears yellow when only 3 clips or fewer remain in the device.
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    K Number
    K230480
    Device Name
    Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
    Manufacturer
    Teleflex Medical
    Date Cleared
    2023-04-28

    (65 days)

    Product Code
    FZP, GDO
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Weck Auto Endo5® Hem-o-lok® ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok® ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel to or tissue structure to be ligated so that the clip completely encompasses the vessel or tissue structure.
    Device Description
    The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier is an automatic, endoscopic applier that is pre-loaded with fifteen (15) Hem-o-lok® medium-large, non-absorbable polymer ligating clips. The applier is a sterile, disposable device that is intended to be used during laparoscopic procedures when ligation of vessels or tissue structures is necessary. The Auto Endo5® 5mm Automatic Endoscopic 35cm Applier employs a trigger grip handle which is housed in a body assembly. The applier is 49cm long with a working length of 35cm. The device is designed for use with a 5/5.5mm cannula and includes a knob to allow 360° rotation of the applier shaft for clip positioning using the index finger of the gripping hand.
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    K Number
    K213813
    Device Name
    DuraFuse Clip and Applier System
    Manufacturer
    NeuraMedica Inc
    Date Cleared
    2022-07-22

    (227 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DuraFuse Clips are indicated for open and tubular retractor procedures of the spine in the prone position for approximation/attachment and/or closure of the dura mater in neurosurgical and orthopedic spine procedures.
    Device Description
    NeuraMedica's DuraFuse Clip is a small, bioabsorbable, non-penetrating clip for rapid closure of the dura mater during spine surgery. DuraFuse Clips are applied individually using the reusable stainless steel NeuraMedica Applier has a low profile that allows visibility for implantation of clips in open or tubular retractor procedures. NeuraMedica DuraFuse Clips are provided sterile and labeled for single use. Dural Clips are sterilized via a validated e-beam dose. NeuraMedica's DuraFuse Applier is autoclavable. It is provided non-sterile.
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    K Number
    K220006
    Device Name
    angioLOCK Polymer Ligating Clip
    Manufacturer
    A2 Medical Systems, LLC
    Date Cleared
    2022-03-02

    (57 days)

    Product Code
    FZP, DSS
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    angioLOCK® Non-Absorbable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    AngioLOCK ligating clips are permanent implant, non-absorbable, sterile single use, surgical clips made of implantable grade polymer and are available in multiple sizes. ligating clips are non-absorbable, non-active implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use. angioLOCK® open and Laparoscopic Ligation Clip Appliers are for use as delivery devices for angioLOCK® Non-Absorbable Polymer Ligation Clips. Other ligation clips cannot be used with these appliers. angioLOCK® Laparoscopic Polymer Ligation Clip Appliers are designed for use with specific size cannulas.
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    K Number
    K202994
    Device Name
    InnoClip Disposable Clip Applier, InnoClip Clip Applier
    Manufacturer
    Taiwan Surgical Corporation
    Date Cleared
    2022-01-04

    (460 days)

    Product Code
    FZP, GDO
    Regulation Number
    878.4300
    Why did this record match?
    Product Code :

    FZP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InnoClip™ Disposable Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking. The InnoClip™ Clip Applier is indicated for patients undergoing laparoscopic surgical procedures involving occlusion of blood vessel, ducts and other tubular structures, and for radiographic marking.
    Device Description
    InnoClip™ Disposable Clip Applier consists of a molded handle and trigger, a 360° rotational knob, a cartridge housing shaft and a pair of jaws which is easy for surgeon to hold the operation field in the natural position. This device includes models DC5T1-BX and DC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves. InnoClip™ Disposable Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Disposable Clip Applier enables the surgeon to apply a maximum number of 10 clips for DC5T1-BX or 16 clips for DC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The pre-loaded clips in the shaft are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger. InnoClip™ Clip Applier has two parts, Reusable Handle and a Disposable Clip Cartridge. The Reusable Handle consists of a molded handle, trigger, openable cover and a 360° rotational knob. The Disposable Clip Cartridge consists of a cartridge housing shaft and a pair of jaws which provide secured of the clip to the targeted vessel. The Disposable Clip Cartridge and the Reusable Handle can be easily assembled together by inserting the Disposable Clip Cartridge through a slot located in the Reusable Handle. This device includes models RC5T1-BX and RC5T1-B6 that are designed to be inserted through 5 mm trocar sleeves. InnoClip™ Clip Applier can be used on vessels or tubular structures. The multi-fire design of InnoClip™ Clip Applier enables the surgeon to apply a maximum number of 10 clips for RC5T1-BX or 16 clips for RC5T1-B6 during a laparoscopic procedure without withdrawing and reinserting the device. The reusable handle design also reduces the surgical cost and waste. The pre-loaded clips in the Disposable Clip Cartridge are advanced to the jaw to enclose and occlude the target vessel by gently pulling the trigger.
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