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510(k) Data Aggregation

    K Number
    K983367
    Device Name
    QLICKSMART
    Manufacturer
    HANDREN ASSOC.
    Date Cleared
    1998-11-06

    (43 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    HANDREN ASSOC.

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

    Permits the safe and simple removal of scalpel blades from most commonly used scalpel handles
    Safely contains the blade immediately upon removal, eliminating the need for further handling prior to disposal
    The counter allows the user to monitor its use to see when it is becoming full and will need changing
    Scalpel handles compatible with the QLICKSMART® include: Swann Morton Blade sizes 3, 4, 7 and 9 Lawton Blade sizes 3 and 4 Martin Blade sizes 3, 4 and 7 Smic Blade sizes 3 and 4 Aesculap Blade sizes 3, 3L, 4 and 7 Sayco Blade sizes 3, 4 and 5 Nopa Blade sizes 3 and 4 Lance Blade sizes 3 and 4 Conqueror Blade size 3 Pro-Med Blade sizes 3 and 4 Paragon Blade sizes 3 and 4 Feather Blade size 7 Rocket Blade size 5 Generic Blade size 4 ab stainless Blade size 4 LRI Blade size 4 Jakobi Blade Size 4
    Scalpel handles known to be incompatible with the QLICKSMART® include: Barron Handle Beaver Type Handles Disposable Handles.

    Device Description

    Not Found

    AI/ML Overview

    This document is a marketing authorization letter for the QLICKSMART® scalpel blade remover, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but these do not raise new questions of safety and effectiveness.

    Therefore, this document does not contain the information requested regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, or ground truth establishment. The FDA letter is a regulatory approval based on demonstrating equivalence, not on the presentation of a de novo clinical or performance study with detailed acceptance criteria and results.

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