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510(k) Data Aggregation

    K Number
    K251687

    Validate with FDA (Live)

    Device Name
    Konig Bell Circumcision Clamp
    Manufacturer
    Medline Industries, LP
    Date Cleared
    2026-02-25

    (268 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Age Range
    All
    Reference & Predicate Devices
    K040052
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Konig Bell Circumcision clamps are reusable instruments used in a medical procedure to compress the foreskin of the penis during the circumcision of male infant or child. Use of the Konig Bell Circumcision clamps in adults is to assist in Human Immunodeficiency Virus (HIV) prevention.

    Device Description

    The Konig Bell Circumcision Clamp is intended to be used in a medical procedure to compress the foreskin of the penis during circumcision of a male infant, child or adult. The device is manufactured from Germangrade 304 stainless steel and is composed of four parts: base, bell, hook arm and thumb screw. The device is offered in the following bell sizes 0.8cm, 1.1cm, 1.3cm, 1.45cm, 1.6cm, 2.1cm, 2.6cm, 2.9cm, 3.2cm and 3.5cm.

    The Konig Bell Circumcision Clamp is packaged in a low-density polyethylene film pouch. The device is provided non-sterile and is intended to be cleaned and sterilized at the healthcare facility prior to use. Validated cleaning and steam sterilization instructions are included in the instructions for use.

    AI/ML Overview

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