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510(k) Data Aggregation

    K Number
    K242923
    Device Name
    SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
    Manufacturer
    Envision Endoscopy
    Date Cleared
    2024-12-20

    (87 days)

    Product Code
    OCZ, DEV
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.
    Device Description
    The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.
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    K Number
    K191900
    Device Name
    Single Use Grasping Forceps
    Manufacturer
    Zhejiang Chuangxiang Medical Technology Co., LTD.
    Date Cleared
    2020-03-27

    (255 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.
    Device Description
    The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
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    K Number
    K152802
    Device Name
    Grasping Forceps
    Manufacturer
    MICRO-TECH (NANJING) CO., LTD.
    Date Cleared
    2016-01-21

    (115 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
    Device Description
    The proposed device Grasping Forceps is a sterile, single-use device, designed to pass through a 2.8 mm or greater working channel of an endoscope. The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.
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    K Number
    K150939
    Device Name
    Ensizor Endoscopic Scissors
    Manufacturer
    SLATER ENDOSCOPY, LLC
    Date Cleared
    2015-06-08

    (62 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and sutures during all flexible endoscopic procedures.
    Device Description
    The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection and the cutting of sutures during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue and suture materials during all flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
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    K Number
    K141058
    Device Name
    ENSIZOR ENDOSCOPIC SCISSORS
    Manufacturer
    SLATER ENDOSCOPY, LLC
    Date Cleared
    2014-08-01

    (99 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during flexible endoscopic procedures.
    Device Description
    The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue during flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.
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    K Number
    K133736
    Device Name
    ENDOSCOPIC SUTURE CUTTER
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2014-01-07

    (29 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US Endoscopy Endoscopic Suture Cutter Device is intended to be used in conjunction with an endoscope to grasp and cut suture in the GI tract.
    Device Description
    Not Found
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    K Number
    K120084
    Device Name
    ENDOSCOPIC RETRIEVAL DEVICE
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2012-05-30

    (140 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
    Device Description
    Not Found
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    K Number
    K103688
    Device Name
    G-PROX EZ ENDOSCOPIC GRASPER
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2011-01-14

    (28 days)

    Product Code
    OCZ, HET
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The USGI g-Prox EZ Endoscopic Grasper is intended for use in minimally Invasive procedures to facilitate tissue grasping and manipulation.
    Device Description
    The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.
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    K Number
    K101298
    Device Name
    ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
    Manufacturer
    ENDOCHOICE, INC.
    Date Cleared
    2010-08-05

    (87 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grasping forceps are intended to be used to grasp tissue and / or retrieve foreign bodies, excised tissue, and stents from within the gastrointestinal tract.
    Device Description
    The EndoChoice grasping forceps are designed for grasping tissue and / or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.
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    K Number
    K072684
    Device Name
    MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
    Manufacturer
    MONDEAL NORTH AMERICA, INC
    Date Cleared
    2008-01-04

    (105 days)

    Product Code
    OCZ, SUB
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    OCZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament. Indications for use: The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following: Endoscopic Gastrocnemius Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment. Endoscopic Plantar Fasciotomy (EPF) – as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of non-surgical treatment. Carpal Tunnel Release (ECTR) - as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.
    Device Description
    The Mondeal Endoscopic Tissue Recession and Release System is a minimally invasive device for gaining exposure to perform Gastrocnemius Tenotomy, Plantar Fasciitis Recession, and Carpal Tunnel Release. The system is comprised of the instruments required to perform the above mentioned maladies in conjunction with commercially available endoscopes. The instruments include an obturator, cannula, cannula locking mechanism, elevator, rasp, suction handle, and knife(s). The system requires bi-portal incisions to pass the cannula from one side of the intended recession/resection to the other, allowing the knife to perform a complete and verified recession/release. The cannula locking mechanism aids the surgeon in ensuring the cannula does not move while performing the procedure. The knife is offered in two different designs. One design is for forward cutting (away from the surgeon), the other is for reverse cutting (towards the surgeon). The benefits of each design are dependent upon which procedure the device is used for and surgeon preference.
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