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510(k) Data Aggregation

    K Number
    K073182
    Device Name
    GYN DISPOSABLES TENACULUM 356T
    Manufacturer
    GYN-DISPOSABLES, INC.
    Date Cleared
    2007-11-28

    (15 days)

    Product Code
    HDC
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K930037,K980247
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYN-DISPOSABLES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To snare, grasp, hold and manipulate cervical and intravaginal tissue.

    Device Description

    GYN Disposables Tenaculum 356T is made of glass reinforced polycarbonate. The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation.

    AI/ML Overview

    The GYN Disposables Tenaculum 356T is a medical device used to snare, grasp, hold, and manipulate cervical and intravaginal tissue. The device is made of glass-reinforced polycarbonate and is supplied sterile by gamma radiation.

    Here's an analysis of the acceptance criteria and the studies that demonstrate the device meets them:

    Acceptance Criteria and Reported Device Performance

    The document describes several tests conducted to ensure the device's safety and performance. The acceptance criteria are generally qualitative (e.g., "met the minimum acceptance criteria," "did not induce cytotoxicity," "passed").

    Test CategoryAcceptance CriteriaReported Device Performance
    Material StrengthThe advanced composite design can easily withstand forces during normal use. The instrument met the minimum acceptance criteria for flexibility, arm strength, tip strength, rack strength, force needed to lock, and hinge pin strength. Does not degrade due to gamma sterilization and extended shelf life.All test reports (flexibility & arm strength, tip strength, rack strength & locking force, hinge pin strength) showed that the instrument met the minimum acceptance criteria. These tests proved that the material does not degrade because of gamma sterilization and extended shelf life.
    BiocompatibilityCytotoxicity: No induction of cytotoxicity relative to positive and negative controls.
    Pyrogenicity/Sensitization/Irritation: No increase in temperature (in rabbits).
    Hemolysis: No damage to blood cells.
    Dermal Sensitization: Passed (in guinea pig).
    Systemic Toxicity (Acute): Passed (in mouse).
    Intracutaneous Irritation: Passed (in rabbit).
    Vaginal Irritation: Passed (in rabbit).
    All tests meet and exceed criteria established in FDA's 510(k) Memorandum #G95, Table 1 for minimal contact duration (
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