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510(k) Data Aggregation

    K Number
    K980123
    Device Name
    CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1998-03-09

    (54 days)

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

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
    Device Description
    Needle-Point Suture Passer Instrument Set
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    K Number
    K971796
    Device Name
    LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1997-08-12

    (89 days)

    Product Code
    EZL, HET, HWC, MBI
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone Anchors is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
    Device Description
    The Laparotomy Bladder Neck Suspension Kit With Bone Anchors is comprised of a template assembly, suture retriever, suture cutter, bone anchors and suture pulling loop. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.
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    K Number
    K971791
    Device Name
    VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1997-07-30

    (76 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparobomy Bladder Neck Suspension is indicated for urethropexy procedures for bladder neck suspension to correct incontinence due to urethral hypermobility.
    Device Description
    The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, suture cutter and suture pulling loop. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.
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    K Number
    K971802
    Device Name
    VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1997-07-30

    (76 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
    Device Description
    The Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is comprised of a template assembly, suture retriever, and suture cutter. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.
    Ask a Question
    K Number
    K971797
    Device Name
    LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1997-07-22

    (68 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility. The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.
    Device Description
    The Laparoscopic Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray. The suture placement system that is offered in the kit is the Laurus Medical Disposable Suture Placement System.
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    K Number
    K971801
    Device Name
    LAPAROTOMY BLADDER NECK SUSPENSION KIT
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1997-07-22

    (68 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
    Device Description
    The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray. The suture placement system that is offered is the Laurus Medical Disposable Suture Placement System.
    Ask a Question
    K Number
    K963076
    Device Name
    LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1997-04-04

    (240 days)

    Product Code
    HET, EZL, JDR
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K960882
    Device Name
    CONTROL SYRINGE
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1996-07-08

    (139 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955535
    Device Name
    LOUISVILLE LABS OXYGEN HEAD TENT
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1996-07-01

    (209 days)

    Product Code
    CBF
    Regulation Number
    868.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOUISVILLE LABORATORIES, INC.

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

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