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510(k) Data Aggregation

    K Number
    K200745
    Device Name
    Lariat, Hot/Cold Snare
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2020-04-21

    (29 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy.
    Device Description
    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.
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    K Number
    K192059
    Device Name
    Bio Guard Air/Water & Suction Valves
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2019-09-17

    (47 days)

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

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioGuard Air/Water Valve is intended to be used to control the air/water function on and endoscope during a Gl endoscopic procedure. The BioGuard Suction Valve is intended to be used to control the suction function on and endoscope during a GI endoscopic procedure.
    Device Description
    Not Found
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    K Number
    K182909
    Device Name
    Roth Net Retriever Product Line
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-11-21

    (35 days)

    Product Code
    FDI, GCJ
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Roth Net Retriever Product Line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
    Device Description
    Not Found
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    K Number
    K182258
    Device Name
    AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-09-21

    (31 days)

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

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K180731
    Device Name
    Ultramatrix EUS Balloon
    Manufacturer
    United States Endoscopy Group, Inc. (US Endoscopy)
    Date Cleared
    2018-04-19

    (30 days)

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

    United States Endoscopy Group, Inc. (US Endoscopy)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.
    Device Description
    Not Found
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    K Number
    K173650
    Device Name
    AquaShield System CO2- Fujifilm
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2018-01-05

    (38 days)

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

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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    K Number
    K172805
    Device Name
    gi-4000 Electrosurgical Generator
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2017-10-23

    (35 days)

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

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gi 4000 Electrosurgical Generator is intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications. The integrated layage pump is intended to was tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes, endoscope water jet channels, or endoscope working channels. The Genii ArConnect™ Conducting Adapter is intended for use with the gi 4000 during argon assisted coagulation.
    Device Description
    Not Found
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    K Number
    K163495
    Device Name
    AdvanCE capsule endoscope delivery device
    Manufacturer
    United States Endoscopy Group, Inc.
    Date Cleared
    2017-03-10

    (87 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Why did this record match?
    Applicant Name (Manufacturer) :

    United States Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device indicated for transendoscopic delivery of Capsules (with the dimensions of 10.5mm - 11.5mm in diameter and 23.5mm in length), to the stomach or duodenum. This device is intended for patients who are either unable to swallow the capsule, or unable to pass the capsule beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.
    Device Description
    The disposable AdvanCE® capsule endoscope delivery device is a 2.5 mm single sheathed device.
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    K Number
    K163492
    Device Name
    Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear
    Manufacturer
    United states Endoscopy Group, Inc.
    Date Cleared
    2017-01-06

    (24 days)

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

    United states Endoscopy Group, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US Endoscopy EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract.
    Device Description
    Not Found
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    K Number
    K153362
    Device Name
    AquaShield system CO2, AquaShield system-PENTAX
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2015-12-16

    (26 days)

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

    UNITED STATES ENDOSCOPY GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.
    Device Description
    Not Found
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