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510(k) Data Aggregation

    K Number
    K142656
    Device Name
    Surgical Gut Suture
    Manufacturer
    COVIDIEN
    Date Cleared
    2015-01-29

    (133 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.
    Device Description
    Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.
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    K Number
    K072930
    Device Name
    DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
    Manufacturer
    DEMETECH CORP.
    Date Cleared
    2008-04-30

    (197 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".
    Device Description
    Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
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    K Number
    K042287
    Device Name
    UNIPLAIN & UNICHROM
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2005-09-07

    (379 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.
    Device Description
    Not Found
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    K Number
    K042897
    Device Name
    AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2004-11-19

    (30 days)

    Product Code
    GAL, GAM, GAP, GAQ, GDF, NBY, NJU
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.
    Device Description
    The AUTOBAHN Tissue Closure Device is a non-sterile, reusable device for use with the AUTOBAHN Disposable Cartridge. The AUTOBAHN Disposable Cartridge is a sterile; single-use disposable cartridge containing a standard type needle and standard, absorbable and non-absorbable, suture that is attached to the reusable AUTOBAHN Tissue Closure Device. The AUTOAHN Tissue Closure Device and Disposable Cartridge are indicated for soft tissue approximation and/ or ligation in general surgical procedures. The needle is contained within the AUTOBAHN Disposable Cartridge before, during, and after the case, aiding in the prevention of suture needle sticks to the surgeons, nurses, and OR staff. The AUTOBAHN tissue Closure Device needle is driven around inside the cartridge in a complete 360° arc. A completed stitch is placed each time the needle and suture are driven across the aperture and through tissue located within the aperture.
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    K Number
    K030227
    Device Name
    SUTURTEK FASTCLOSE SUTURING DEVICE
    Manufacturer
    SUTURTEK INCORPORATED
    Date Cleared
    2003-03-17

    (54 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures. The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures. It is designed to aid in the prevention of suture needle stick injuries.
    Device Description
    The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.
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    K Number
    K020597
    Device Name
    SERRALGUT
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-08-14

    (173 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
    Device Description
    Not Found
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    K Number
    K021043
    Device Name
    GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
    Manufacturer
    GRAMSMED LLC
    Date Cleared
    2002-06-21

    (81 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
    Device Description
    Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
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    K Number
    K011105
    Device Name
    SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
    Manufacturer
    QRC CONSULTING
    Date Cleared
    2001-05-30

    (49 days)

    Product Code
    GAL, GAB, HCF
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001299
    Device Name
    PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
    Manufacturer
    CP MEDICAL
    Date Cleared
    2000-06-23

    (60 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K000542
    Device Name
    PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
    Manufacturer
    ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
    Date Cleared
    2000-04-28

    (71 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Product Code :

    GAL

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

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