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510(k) Data Aggregation

    K Number
    K250411
    Device Name
    DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System
    Manufacturer
    Dannik, LLC
    Date Cleared
    2025-03-12

    (27 days)

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

    Dannik, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval Devices are indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgery.
    Device Description
    The DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with a deployment mechanism. The bag is supplied pre-loaded in the introducer assembly and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment of the bag with the use of the biasing arms.
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    K Number
    K211019
    Device Name
    Disposable Monopolar Laparoscopic Tips and Reusable Handles
    Manufacturer
    Dannik LLC
    Date Cleared
    2021-10-28

    (206 days)

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

    Dannik LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.
    Device Description
    The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors. The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
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    K Number
    K210569
    Device Name
    Disposable Monopolar Laparoscopic Shafts and Reusable Handles
    Manufacturer
    Dannik LLC
    Date Cleared
    2021-08-16

    (171 days)

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

    Dannik LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
    Device Description
    The Disposable Monopolar Laparoscopic Shafts and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The Disposable Monopolar Laparoscopic Shafts are offered in working diameters of 3 to 5 mm and lengths between 20 to 45 cm. The shaft is made from aluminum covered with a fluorinated ethylene polypropylene external insulation. The shaft is attached to the handle using the locking knob and a stainless-steel drive rod which connects to the jaws and interacts with the handle activation rod. The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. Handles are offered in ratcheting and non-ratcheting configurations and are intended to be connected to the sterile disposable shaft. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
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    K Number
    K201063
    Device Name
    DANNIK Disposable Monopolar Laparoscopic Instrument
    Manufacturer
    Dannik
    Date Cleared
    2020-06-09

    (49 days)

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

    Dannik

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
    Device Description
    The DANNIK Disposable Monopolar Laparoscopic Instruments are sterile single-use devices consisting of a handle, rotator knob and shaft. The handle activates the instrument jaws and scissor blades. The rotator knob provides 360 degrees of rotation for the instrument shaft and jaws. The shaft includes an external insulation that runs from the rotator knob to the instrument jaws and is provided in working diameters of 3 to 5 mm and lengths up to 33 cm. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
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    K Number
    K200053
    Device Name
    DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)
    Manufacturer
    DANNIK
    Date Cleared
    2020-04-21

    (102 days)

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

    DANNIK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK Specimen Retrieval System is in surgical procedures to capture organs or tissue to be removed from the body cavity during Laparoscopic Surgery via extracorporeal manual morcellation. The DANNIK Specimen Retrieval System is contraindicated for laparoscopic power morcellation during gynecologic procedures. The DANNIK Specimen Retrieval System is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
    Device Description
    The DANNIK Specimen Retrieval System are sterile single patient use devices, which comprise of a flexible plastic bag with and without a deployment mechanism. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. The DANNIK Specimen Retrieval System is comprised of a flexible plastic bag with and without a deployment mechanism. The bag is made from polyurethane and/or rip-stop nylon and consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. The bags come in sizes from 50 to 3000 mL. The deployment mechanism consists of a push-pull rod and introducer assembly. The push-pull rod consists of a handle, shaft and biasing arms and is made from a combination of Stainless Steel, Nitinol, ABS, and PC. The introducer assembly consists of a tube and is made from ABS and/or PC. The deployment mechanism allows easy insertion through the cannula and full deployment the use of the metallic biasing arms. Introducers range from 5 to 15 mm in diameter. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
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    K Number
    K193019
    Device Name
    DANNIK Disposable Monopolar Laparoscopic Instrument
    Manufacturer
    Dannik
    Date Cleared
    2020-03-04

    (127 days)

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

    Dannik

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
    Device Description
    The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode. This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
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    K Number
    K192711
    Device Name
    Dannik Titanium Ligation Clip
    Manufacturer
    Dannik
    Date Cleared
    2019-12-20

    (84 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dannik

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK Titanium Ligation Clips is designed for the intended use of ligating blood vessels .The Clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The DANNIK Titanium Ligation, clip can be left in vivo without sequela as it is biologically inert.
    Device Description
    The DANNIK Titanium Ligation Clips are exclusively made of titanium and supplied in four different sizes: small, medium-large, and large. Packaged in cartridge of six clip units. The titanium used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium". This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
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    K Number
    K192643
    Device Name
    Dannik Laparoscopic Suction Irrigation System
    Manufacturer
    Dannik
    Date Cleared
    2019-11-19

    (56 days)

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

    Dannik

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, and tissue debris from the surgical site
    Device Description
    The DANNIK Laparoscopic Suction Irrigation System is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris from the surgical site. The system consists of a hand piece equipped with two trumpet style valves, a probe and connecting lines of tubing, one set designated to attach to supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure. This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
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