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510(k) Data Aggregation

    K Number
    K993970
    Device Name
    MICRINS MICROSURGICAL SUTURE
    Manufacturer
    MICRINS SURGICAL, INC.
    Date Cleared
    2000-03-30

    (128 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRINS SURGICAL, INC.

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

    Micrins microsurgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a "Microsurgical Suture" device, indicating that the device is substantially equivalent to previously reclassified devices. It outlines indications for use, limitations on manufacturing materials, and regulatory requirements, but it does not detail specific performance studies or acceptance criteria for device performance.

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    K Number
    K982278
    Device Name
    MICRINS MICRO ANASTOMOSIS CLAMP
    Manufacturer
    MICRINS SURGICAL, INC.
    Date Cleared
    1999-03-26

    (270 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRINS SURGICAL, INC.

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

    The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the microanastomosis has been completed the micro clamp is removed from the patient

    Device Description

    The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm.

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Micrins Micro Anastomosis Clamp (K982278). It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance data against predefined acceptance criteria.

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