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510(k) Data Aggregation

    K Number
    K213274
    Device Name
    Qlicksmart BladeFlask UNIVERSAL
    Manufacturer
    Qlicksmart Pty Ltd.
    Date Cleared
    2022-06-22

    (265 days)

    Product Code
    MMK
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Qlicksmart Pty Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function intended to permit the safe removal of scalpel blades from most currently available scalpel handles and contain the blade immediately upon removal to eliminate the need for further handling prior to be disposed as medical waste while allowing the user to monitor its use to see when it is becoming full and will need changing. Scalpel handles compatible with the Qlicksmart BladeFlask PLUS include: - Swann Morton sizes 3. 4. 5. 6. 7. 8. and 9 - Lawton size 4 - Martin sizes 3, 4, and 7 - Aesculap sizes 3. 4. 6. and 7 - Sayco sizes 3, 4, and 5 - Smic sizes 3 and 4 - Nopa sizes 3 and 4 - AB Stainless size 4 - Lance sizes 3 and 4 - Pro-Med sizes 3 and 4 - Paragon sizes 3 and 4 - Rocket size 5 - Conqueror size 3 - Feather sizes 3. 4. and 7 - LRI sizes 3 and 4 - Generic handle size 4 - L-dent - Medesy size 5 - Jakobi size 4 - CS size 5 - Helmut Zepf Scalpel handles known to be incompatible with the Qlicksmart BladeFlask PLUS include: - Beaver type handles - Disposable handles
    Device Description
    The Qlicksmart BladeFlask PLUS is a single-use sharps container with a scalpel blade removal function that is used under non-sterile conditions. The Qlicksmart BladeFlask PLUS removes scalpel blades from scalpel handles in a single-handed action and then immediately contains the used scalpel blade inside the Qlicksmart BladeFlask PLUS. The handle is intended to be used to dispose the entire container as hazardous waste when full (100 removed blades and shut-off system is activated) and the device is not intended to be reprocessed. The Qlicksmart BladeFlask PLUS combines a hard plastic sharps container with an internal blade remover mechanism made of hard plastic and hardened steel parts. It is approximately (13.5 cm) tall by (9.1 cm) wide by (12.3 cm) deep. It weighs less than 250gm per unit when empty. It is red in color. It is labelled as shown on the samples provided with this application.
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