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510(k) Data Aggregation

    K Number
    K973082
    Device Name
    VENTRAL WALL DEFECT REDUCTION SILO
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1997-11-04

    (78 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Specialty Surgical Products Ventral Wall Defect Reduction Silo is indicated for use in the treatment of I he opecially burgiour routed "remat" oschisis and ompalocele, where primary closure attempts must be abandoned in favor of a staged repair.

    Device Description

    Ventral Wall Defect Reduction Silo

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Ventral Wall Defect Reduction Silo." This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

    A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. This process generally relies on comparing the new device's technological characteristics and indications for use to a predicate device, rather than requiring new clinical studies with pre-defined acceptance criteria and performance metrics.

    Therefore, I cannot extract the requested information from the provided text. The document is solely a regulatory approval letter.

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