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510(k) Data Aggregation

    K Number
    K213223
    Device Name
    Multi-Band Ligator
    Manufacturer
    Beijing ZKSK Technology Co.,Ltd
    Date Cleared
    2022-06-06

    (250 days)

    Product Code
    FHN, MND
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
    Device Description
    Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.
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    K Number
    K172985
    Device Name
    Ligation Device
    Manufacturer
    Leo Medical Co., Ltd.
    Date Cleared
    2018-06-14

    (260 days)

    Product Code
    FHN, MND
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to control bleeding following polypectomy of pedunculated polyps.
    Device Description
    The Ligation Device is sterile and single-use, which consists of two main components, ligation loop and delivery system. And these two components provided in different sizes to consist different specifications of ligation device.
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    K Number
    K150718
    Device Name
    Wi-3 HAL-RAR System
    Manufacturer
    AGENCY FOR MEDICAL INNOVATIONS GMBH
    Date Cleared
    2015-06-12

    (85 days)

    Product Code
    FHN, IYN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary.
    Device Description
    The Wi-3 HAL-RAR System is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, manually ligating these arteries, and subsequently carrying out a mucopexy of hemorrhoidal prolapse if necessary. "HAL" is an acronym referring to "Hemorrhoidal Arteries Ligation", and "RAR" is an acronym referring to "Recto Anal Repair." The Wi-3 HAL-RAR System is designed for use in a surgical suite or operating room. The Wi-3 HAL-RAR System includes components that come in contact with the patient during use. The RAR Probes (made of acrylic-based multipolymer) and Sleeve (PBT) are external communicating devices having limited contact duration (< 24 hours) with tissue. The Wi-3 Arm (made of Aluminum Alloy) and Wi-3 Fixation Nut (made of polyphenylsulfone and acetal) are surface devices having limited contact duration (< 24 hours) with skin.
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    K Number
    K131282
    Device Name
    NEXUS HEMORRHOID LIGATOR
    Manufacturer
    INX MEDICAL
    Date Cleared
    2013-07-11

    (66 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The inx Medical Nexus™ Hemorrhoid Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel in hospitals, clinics, and doctors' offices.
    Device Description
    The inx Medical Nexus™ Hemorrhoid Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The inx Medical Nexus™ Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.
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    K Number
    K093497
    Device Name
    THD BANDY
    Manufacturer
    THD SPA
    Date Cleared
    2010-07-15

    (245 days)

    Product Code
    FHN, REG
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.
    Device Description
    The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.
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    K Number
    K091519
    Device Name
    HAEMOBAND MULTI-LIGATOR
    Manufacturer
    HAEMOBAND SURGICAL LTD.
    Date Cleared
    2009-07-28

    (67 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel.
    Device Description
    The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands.
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    K Number
    K070881
    Device Name
    LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
    Manufacturer
    SAPI MED S.P.A
    Date Cleared
    2007-09-26

    (180 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
    Device Description
    The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.
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    K Number
    K020824
    Device Name
    SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2002-04-12

    (29 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids. The Injection Speedband™ Superview Super 7 is indicated for endoscopic treatment of esophageal varices utilizing combination ligation therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.
    Device Description
    The Speedband Superview Super7 and Injection Speedband Superview Super7 consist of two main components; a ligating unit and a handle assembly. The ligating unit consists of a cylindrical housing with a flexible silicone endoscope adapter, and seven elastic ligating bands. Suture is threaded around each band and passes through suture slots around the perimeter of the housing. The suture enters the endoscope through the working channel of an endoscope and is secured the tripwire on the handle assembly durning set-up. The handle assembly consists of a handle knob and plastic spool mounted on a bracket with a stem. A tripwire is attached to the spool and passes through the septum and into the stem. The stem fits into the working channel of the endoscope. The septum seals the channel so suction can be maintained. On the Injection models, the septum has a port for insertion of an injection therapy needle.
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    K Number
    K020526
    Device Name
    MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
    Manufacturer
    DON WILSON/WILSON-COOK MEDICAL, INC.
    Date Cleared
    2002-03-19

    (28 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Used to ligate internal hemorrhoids.
    Device Description
    The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only. The modification of the predicate Wilson-Cook Multiple Band Ligator (K944220/A) consists of a change to the handle in order to accommodate single-hand operation through an anoscope. In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the modified Multiple Band Ligator is used in conjunction with an anoscope. The barrel and bands of the modified device are identical to the barrel and bands of the Wilson-Cook Multiple Band Ligator in the choice of the production and the specifications of each. The trigger cord is comprised of the same materials, however the trigger cord is slightly shorter in length for the modified devices, as the modified device comes preloaded and is used with an anoscope. Loading catheter and irrigation adapter are not needed.
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    K Number
    K001236
    Device Name
    RIZA BAND STRETCHER (RBS)-60000
    Manufacturer
    R-MED, INC.
    Date Cleared
    2000-07-17

    (90 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Product Code :

    FHN

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