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510(k) Data Aggregation

    K Number
    K131373
    Device Name
    SHANGRING
    Manufacturer
    WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY
    Date Cleared
    2013-06-25

    (43 days)

    Product Code
    HFX
    Regulation Number
    884.4530
    Type
    Special
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY

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

    The ShangRing™ Circumcision Clamp intended use is for circumcision of adult males, defined as circumferential excision of the foreskin or prepuce at or near the level of the coronal sulcus.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a FDA 510(k) clearance letter and an Indications for Use statement for the ShangRingTM Circumcision Clamp. These documents do not contain any information regarding acceptance criteria, device performance results, study details (sample sizes, data provenance, expert qualifications, adjudication methods), or ground truth establishment methods.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

    To answer your request, I would need a different set of documents, such as a summary of safety and effectiveness data, a clinical study report, or a premarket submission document that details the performance testing and acceptance criteria for the ShangRingTM Circumcision Clamp.

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